K170718 · Iridex Corporation · GEX · May 3, 2017 · General, Plastic Surgery
Device Facts
Record ID
K170718
Device Name
Iridex TruFocus LIO Premiere
Applicant
Iridex Corporation
Product Code
GEX · General, Plastic Surgery
Decision Date
May 3, 2017
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulseTM or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows: 532 nm: Dermatology: - Pigmented Skin Lesions - Vascular Lesions Ear, Nose, and Throat (ENT)/ Otolaryngology: Otosclerotic Hearing loss and/or diseases of the inner ear: - Stapedectomy - Stapedotomy - Myringotomies - Lysis of Adhesions - Control of Bleeding - Removal of Acoustic Neuromas - Soft tissue Adhesion in Micro/Macro Otologic Procedures Ophthalmology: Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including: - Retinal photocoagulation (RPC) for the treatment of - Diabetic retinopathy, including: - Nonproliferative retinopathy - Macular edema - Proliferative retinopathy - Retinal tears and detachments - Lattice degeneration - Age-related macular degeneration (AMD) - Retinopathy of prematurity - Sub-retinal (choroidal) neovascularization - Central and branch retinal vein occlusion - Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including - Primary open angle/Closed angle 577nm Dermatology: - Treatment of Vascular and pigmented lesions Ophthalmology: Indicated for use in photocoagulation of both anterior and posterior segments including: · Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - Proliferative and nonproliferative diabetic retinopathy; - Choroidal neovascularization: - Branch retinal vein occlusion; - Age-related macular degeneration - Retinal tears and detachments - Retinopathy of prematurity - · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma 630 - 670nm Ophthalmology: Indicated for use in photocoagulation of both anterior and posterior segments including: · Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - Proliferative and non-proliferative diabetic retinopathy; - Choroidal neovascularization: - Branch retinal vein occlusion: - Age-related macular degeneration - Retinal tears and detachments - Retinopathy of prematurity - · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma 810nm Ophthalmology: Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples: - Retinal photocoagulation for the treatment of: - Diabetic retinopathy, including: - Nonproliferative retinopathy - Macular edema - Proliferative retinopathy - Retinal Tears, Detachments and Holes - Lattice degeneration - Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) - Retinopathy of prematurity - Sub-retinal (choroidal) neovascularization - Central and Branch Retinal Vein Occlusion - Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including: - Primary open angle - Closed angle - Refractory Glaucoma (recalcitrant/uncontrolled)
Device Story
Head-mounted laser indirect ophthalmoscope (LIO) used with Iridex IQ laser systems; delivers laser energy (532nm, 577nm, 630-670nm, 810nm) via fiber optics for transpupillary photocoagulation. Used by ophthalmologists to visualize peripheral retina and perform treatments on patients, including infants, in supine position. Device features binocular visualization, LED illumination (optional halogen), and air-cooled design. Connects to laser console; utilizes RFID for laser-to-device communication. Output is focused laser energy for tissue coagulation, vaporization, or ablation. Benefits include precise retinal treatment and versatility across ophthalmic, dermatologic, and ENT procedures.
Clinical Evidence
Bench testing only. Compliance with ISO 15004-2 (ophthalmic instruments), IEC 60601-1 (electrical safety), IEC 60601-2-22 (laser surgical equipment), IEC 60825-1 (laser safety), IEC 60601-1-6, and IEC 62366 (usability) demonstrated safety and effectiveness.
Technological Characteristics
Headband-mounted binocular indirect ophthalmoscope; LED illumination (optional halogen); air-cooled; fiber optic delivery; 370mm working distance; 1.1mm/4.0mm spot sizes. Powered by Heine rechargeable battery (100-240VAC). Standards: ISO 15004-2, IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 62366.
Indications for Use
Indicated for patients requiring laser photocoagulation, trabeculoplasty, iridotomy, or iridoplasty for ocular conditions including diabetic retinopathy, macular edema, retinal tears/detachments, AMD, retinopathy of prematurity, and glaucoma. Also indicated for dermatology (vascular/pigmented lesions) and ENT (otosclerotic hearing loss, stapedectomy, stapedotomy, myringotomies, lysis of adhesions, bleeding control, acoustic neuroma removal).
Regulatory Classification
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized representation of a human form below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2017
Iridex Corporation Gloria Dy Regulatory Compliance Associate 1212 Terra Bella Avenue Mountain View, CA 94043-1824
Re: K170718
Trade/Device Name: Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: March 7, 2017 Received: March 9, 2017
Dear Gloria Dy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K170718
#### Device Name
Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532m], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
#### Indications for Use (Describe)
The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577mm], IQ 630-670 [630mm-670mm], IQ 810 [810mm]), hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, M or LongPulse TM mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
532 nm:
Dermatology:
- · Pigmented Skin Lesions
- · Vascular Lesions
Ear, Nose, and Throat (ENT)/ Otolaryngology
Otosclerotic Hearing loss and/or diseases of the inner ear:
- · Stapedectomy
- · Stapedotomy
- · Myringotomies
- · Lysis of Adhesions
- · Control of Bleeding
- · Removal of Acoustic Neuromas
- · Soft tissue Adhesion in Micro/Macro Otologic Procedures
#### Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:
- · Retinal photocoagulation (RPC) for the treatment of
- Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- · Retinal tears and detachments
- Lattice degeneration
- Age-related macular degeneration (AMD)
- Retinopathy of prematurity
- Sub-retinal (choroidal) neovascularization
- Central and branch retinal vein occlusion
- · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
- Primary open angle/Closed angle
#### 577nm
Dermatology:
- · Treatment of Vascular and pigmented lesions
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including :
- Proliferative and nonproliferative diabetic retinopathy;
{3}------------------------------------------------
- Choroidal neovascularization;
- Branch retinal vein occlusion;
- Age-related macular degeneration
- Retinal tears and detachments
- Retinopathy of prematurity
- · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma
## 630 - 670nm
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and non-proliferative diabetic retinopathy;
- Choroidal neovascularization:
- Branch retinal vein occlusion;
- Age-related macular degeneration
- Retinal tears and detachments
- Retinopathy of prematurity
- · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma
## 810nm
Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:
- Retinal photocoagulation for the treatment of:
- Diabetic retinopathy, including:
- Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
- Retinal Tears, Detachments and Holes
- Lattice degeneration
- Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
- Retinopathy of prematurity
- Sub-retinal (choroidal) neovascularization
- Central and Branch Retinal Vein Occlusion
- Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:
- Primary open angle
- Closed angle
- Refractory Glaucoma (recalcitrant/uncontrolled)
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
{4}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{5}------------------------------------------------
## 510(k) Summary
## Summary prepared on Date: April 27, 2017
#### 510(k) Submitter/Holder:
Iridex Corporation 1212 Terra Bella Avenue Mountain View, CA 94043
# Contact:
Gloria Dy Regulatory Compliance Associate Telephone: 650-605-8807 Fax: 650-962-0486 Email: gdy@iridex.com
# Name of Device:
Trade Name: Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IO 577 [577nm], IQ 630-670 [630mm-670mm], hand pieces, delivery devices & accessories
| Common Name: | Laser Indirect Ophthalmoscope |
|----------------------|------------------------------------------------------|
| Classification Name: | Laser Powered Surgical Instruments (and Accessories) |
# Predicate Device:
| Trade Name: | Iridex TruFocus LIO+ Laser Indirect Ophthalmoscope |
|----------------------|------------------------------------------------------|
| Common Name: | Laser Indirect Ophthalmoscope |
| Classification Name: | Laser Powered Surgical Instruments (and Accessories) |
| 510(k) Number: | K071687 |
| Manufacturer: | IRIS Medical Instruments, Inc. /Iridex Corporation |
# Device Description:
Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630mm-670mm], and IQ 810 [810mm]), hand pieces, delivery devices & accessories is a delivery accessory used with the Iridex family of IQ laser systems (IQ532, IQ577, and IQ810). Iridex TruFocus LIO Premiere and the Family of Iridex® IO Laser Systems (10 532 1532nm), 10 577 [577mm], IQ 630-670 [630nm-670mm], IQ 810 [810nm]), hand pieces, delivery devices & accessories is a headmounted diagnostic indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient's retina. It allows binocular visualization of the peripheral retina not easily viewed at the slit lamp and can be used to evaluate and treat patients, including infants, while they are in a supine position.
Premarket Notification Traditional 510(k) Page 1 of 6 Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
{6}------------------------------------------------
The LIO is a laser delivery device used to perform transpupillary laser photocoagulation during noninvasive ocular surgical procedures. The LIO is supplied non-sterile and is intended for reuse.
Variants of the device may relate to the style of headband, laser wavelength to be delivered, and the device to laser connector (i.e. RFID).
# Intended Use:
Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulseTM or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
532 nm:
Dermatology:
- · Pigmented Skin Lesions
- Vascular Lesions
Ear, Nose, and Throat (ENT)/ Otolaryngology:
Otosclerotic Hearing loss and/or diseases of the inner ear:
- · Stapedectomy
- · Stapedotomy
- · Myringotomies
- Lysis of Adhesions
- Control of Bleeding
- Removal of Acoustic Neuromas
- · Soft tissue Adhesion in Micro/Macro Otologic Procedures
Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including:
- · Retinal photocoagulation (RPC) for the treatment of
- Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
# Premarket Notification Traditional 510(k)
Page 2 of 6
Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
{7}------------------------------------------------
- Proliferative retinopathy
- Retinal tears and detachments
- Lattice degeneration
- Age-related macular degeneration (AMD)
- Retinopathy of prematurity
- Sub-retinal (choroidal) neovascularization
- Central and branch retinal vein occlusion
- · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
- Primary open angle/Closed angle
# 577nm
Dermatology:
- · Treatment of Vascular and pigmented lesions
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and nonproliferative diabetic retinopathy;
- Choroidal neovascularization:
- Branch retinal vein occlusion;
- Age-related macular degeneration
- Retinal tears and detachments
- Retinopathy of prematurity
- · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma
630 - 670nm
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
Premarket Notification Traditional 510(k) Page 3 of 6 Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
{8}------------------------------------------------
· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and non-proliferative diabetic retinopathy;
- Choroidal neovascularization:
- Branch retinal vein occlusion:
- Age-related macular degeneration
- Retinal tears and detachments
- Retinopathy of prematurity
- · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma
810nm
Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:
- Retinal photocoagulation for the treatment of:
- Diabetic retinopathy, including:
- . Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- Retinal Tears, Detachments and Holes
- Lattice degeneration
- Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
- Retinopathy of prematurity
- Sub-retinal (choroidal) neovascularization
- Central and Branch Retinal Vein Occlusion
- Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:
- Primary open angle
- Closed angle
- Refractory Glaucoma (recalcitrant/uncontrolled)
# Technological Characteristics:
Premarket Notification Traditional 510(k) Page 4 of 6 Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
{9}------------------------------------------------
The technological characteristics of the Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532nm], 10 630-670 [630mm-670mm], and 10 810 [810mm]), hand pieces, delivery devices & accessories are substantially equivalent to those of the predicate device. Iridex TruFocus LIO+ Laser Indirect Ophthalmoscope (K071687). See Table 8-1 below.
# Safety and Effectiveness:
The ISO 15004-2 testing proves that the proposed device design meets the accepted design standards for this type of device. Additionally, testing to the following standards IEC60601-2, IEC60601-1, IEC60825-1, IEC60601-2-22, IEC60601-1-6 and IEC62366 prove the safety and effectiveness of this device. A comparison of the technological characteristics proves that technological differences do not raise different questions of safety and effectiveness.
# Conclusion:
The Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532mm], 10 577 [577nm], IQ 630-670 [630nm-670mm], and IQ 810 [810mm]), hand pieces, delivery devices & accessories was found to be substantially equivalent to the predicate device - Iridex TruFocus LIO+ (K071687).
The Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532mm], 10 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810mm]), hand pieces, delivery devices & accessories shares identical indications for use, similar design features, and functional features with the predicate Iridex TruFocus LIO+ and therefore is substantially equivalent.
The Iridex TruFocus LIO Premiere with the Family of Iridex® IO Laser Systems (10 532 [532m], IO 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810mm]), hand pieces, delivery devices & accessories was found to be as safe, as effective and performs as well as or better than the predicate Iridex TruFocus LIO+ Laser Indirect Ophthalmoscope.
Table 8-1: Salient characteristics of the Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532nm], 10 577 [577nm], 10 630-670 [630nm-670nm], and 10 810 [810mm]), hand pieces, delivery devices & accessories and the predicate devices.
| | Iridex TruFocus LIO Premiere with<br>the Family of Iridex® IQ Laser<br>Systems (IQ 532 [532nm], IQ 577<br>[577nm], IQ 630-670 [630nm-<br>670nm], IQ 810 [810nm]), hand<br>pieces, delivery devices & accessories | Iridex TruFocus LIO+ Laser<br>Indirect Ophthalmoscope |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| 510(k) applied and<br>(predicate devices) | New device for which this Traditional<br>510(k) is being submitted | 510(k) number: K071687 |
| Classification<br>Product Code | GEX - Powered Laser Surgical<br>Instrument | GEX - Powered Laser Surgical<br>Instrument |
| Intended Use | Retinal photocoagulation. | Retinal photocoagulation. |
| Type/Design | Indirect Ophthalmoscope Binocular<br>(Headband mounted) | Indirect Ophthalmoscope Binocular<br>(Headband mounted) |
| Treatment<br>Wavelength | 532nm, 577nm, 810nm | 532nm, 577nm, 810nm, 630nm, 670nm |
Premarket Notification Traditional 510(k)
Page 5 of 6
Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
{10}------------------------------------------------
| Eye Filter OD | 6 @ 532 nm & 577nm, 2 @ 810 nm | 6 @ 532 nm & 577nm, 2 @ 810 nm |
|---------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Working Distance | 370mm +/- 10mm | 370mm +/- 10mm |
| Fiber Length | 13'8" | 13'8" |
| Aerial Spot Size | Standard LIO spot size: 1.1mm<br>(0.043in) ±10% | Standard LIO spot size: 1.1mm<br>(0.043in) ±10% |
| | Large LIO spot size: 4.0mm (0.157in)<br>±10% | Large LIO spot size: 4.0mm (0.157in)<br>±10% |
| Illumination Source | LED Illumination light source standard<br>with optional Halogen bulb | Halogen Lamp |
| Cooling System | Air Cooled | Air Cooled |
| Electrical | Heine rechargeable battery. Operates<br>on 100-240VAC, 50/50Hz. Optional<br>wall plug in charger. | 6V DC from Iridex Laser console |
| Weight | ≤ 1000gm (2.2 lbs.) with battery<br>installed | 1.2 lbs. |
Premarket Notification Traditional 510(k) Page 6 of 6 Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
