Who is the manufacturer of SCANNING LASERLINK?

Lumenis, Inc. filed the 510(k) submission for SCANNING LASERLINK (K130195).

What is the FDA product code for SCANNING LASERLINK?

HQF. It is classified under 21 CFR 886.4390 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for SCANNING LASERLINK?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like SCANNING LASERLINK?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SCANNING LASERLINK

K130195 · Lumenis, Inc. · HQF · Nov 1, 2013 · Ophthalmic

Device Facts

Record ID	K130195
Device Name	SCANNING LASERLINK
Applicant	Lumenis, Inc.
Product Code	HQF · Ophthalmic
Decision Date	Nov 1, 2013
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 886.4390
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The Lumenis® Array™ LaserLink™ device is a laser system accessory intended for use in the treatment of ocular pathology. For the posterior segment, the Lumenis® Array™ LaserLink™ device is indicated for use in retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and severe and very severe nonproliferative diabetic retinopathy; Macular edema associated with proliferative or nonproliferative diabetic retinopathy; Choroidal neovascularization; Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion; Central retinal vein occlusion); Macular edema associated with Branch retinal vein occlusion; Retinal tears and detachments. And anterior segments as follows: Iridotomy in closed angle glaucoma; Trabeculoplasty in open angle glaucoma.

Device Story

Lumenis Array LaserLink is a delivery system accessory for ophthalmic laser systems (Novus Spectra, Vision One). It adapts an examination slit lamp for therapeutic laser delivery. The device includes a module, console, touchscreen display, and remote touchpad. The module attaches to the slit lamp to deliver the treatment beam. The console houses control electronics and power supply. The touchscreen allows clinicians to adjust laser mode, energy, and aiming beam intensity. The touchpad enables micromanipulation of beam position, power, spot size, and pattern parameters. It utilizes a scanning pattern generator to deliver predefined treatment patterns (e.g., square, arc, line, circle) to target ocular tissue. Used in clinical settings by ophthalmologists to treat retinal and anterior segment pathologies. Output is a controlled laser beam for photocoagulation or retinopexy, aiding in the management of vascular and structural ocular abnormalities.

Clinical Evidence

Bench testing only. The device underwent electrical safety and EMC testing per IEC 60601 series, side-by-side comparative performance assessments against competitive products, and protocol-governed verification and validation to ensure design specifications were met.

Technological Characteristics

Delivery system accessory for ophthalmic lasers. Features scanning pattern generator, touchscreen interface, and remote touchpad. Compatible with 532nm, 577nm, and 659nm laser wavelengths. Power input 100-240 VAC. Operates as an attachment to standard slit lamps.

Indications for Use

Indicated for patients requiring retinal photocoagulation or panretinal photocoagulation for diabetic retinopathy, macular edema, choroidal/retinal neovascularization, retinal tears/detachments, or glaucoma (iridotomy/trabeculoplasty).

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Predicate Devices

Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi (K111493)
Topcon PASCAL Streamline 577 (K111108)
Topcon (OptiMedica) PASCAL Streamline Photocoagulator (K100019)
Lumenis Vision One Laser System (K111213)

Submission Summary (Full Text)

{0}------------------------------------------------ ડ. 510(k) SUMMARY ### 510(k) Summary **NOV 0 1 2013** #### I. Submitter General Information: | Device Owner Name: | Lumenis, Inc. | |----------------------|--------------------------------------------------| | Address: | 3959 West 1820 South Salt Lake City, UT 84104 | | Contact: | Jace R. McLane | | Phone: | 801-656-2328 | | Fax: | 801-656-2415 | | Date of Preparation: | March 1, 2013 | | Device Name: | | | Trade Name: | Lumenis ® ArrayTM LaserLinkTM | #### Common/Usual Name(s): Surgical Laser Class: Class II Classification Name(s): HQF, Laser, Ophthalmic CFR Reference: 21 CFR § 886.4390, Ophthalmic Laser III. Predicate Device Name(s): II. Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi Trade Name(s): (#K111493). Topcon PASCAL Streamline 577 (#K111108). Topcon (OptiMedica) PASCAL Streamline Photocoagulator (#K100019) Lumenis Vision One Laser System (#K111213) #### IV. Device Description: The Lumenis® Array™ LaserLink™ device is a delivery system that adapts an examination slit lamp for use as a therapeutic laser delivery system, utilizing a scanning pattern generator to deliver predefined patterns of treatment. The Lumenis® Array™ LaserLink™ device is comprised of the following components: - ArrayTM LaserLink™M module . - . Console - . Touchscreen display - Remote touchpad . The Array™ LaserLink™ module attaches to the slit lamp and delivers the treatment beam to the target tissue. The console houses the control electronics and power supply, and integrates the Array™ LaserLinkTM module with the laser system. T. 801-656-2300 F. 801-656-2415 www.lumenis.com Image /page/0/Picture/19 description: The image shows the word "LUMENIS" in a stylized font. To the left of the word is a circular graphic with lines inside. The word "LUMENIS" is in all capital letters, and there is a small circle above and to the right of the "S". The image is in black and white. {1}------------------------------------------------ The touchscreen display is used to adjust laser treatment settings, such as laser mode, energy, and aiming beam intensity. It can be positioned on either side of the slit lamp, and duplicates the functions of the laser's remote control. The touchpad is used to micromanipulate the position of the aiming and treatment beams, adjust laser power, spot size, the number of spots, and pattern parameters. #### V. Intended Use: Device Name: Lumenis® Array™ LaserLinkTM Indications for Use: The Lumenis® Array™ LaserLink™ device is a laser system accessory intended for use in the treatment of ocular pathology. - For the posterior segment, the Lumenis® ArrayTM LaserLink™ . device is indicated for use in retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: - o Proliferative and severe and very severe nonproliferative diabetic retinopathy - o Macular edema associated with proliferative or nonproliferative diabetic retinopathy - o Choroidal neovascularization - o Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion; Central retinal vein occlusion) - o Macular edema associated with Branch retinal vein occlusion - o Retinal tears and detachments - And anterior segments as follows: . - o Iridotomy in closed angle glaucoma - o Trabeculoplasty in open angle glaucoma The Lumenis Laser Systems compatible for connection with the Lumenis® Array™ LaserLink™ device are: - Novus Spectra™ Laser System (K022327)(532nm) . - Novus Spectra™ Dual Port Laser System (K022327)(532nm) . - . Vision One™ Laser System (K111213)(532nm, 577nm, 659nm) ### Table 2 Pattern Indications For Use | Condition | Treatment | Pattern Selection Option | Specific Pattern | |------------------------------------|-----------------------------|--------------------------------|--------------------------------------------------| | Posterior segment: Retina | | | | | Proliferative Diabetic Retinopathy | Panretinal Photocoagulation | Yes | All patterns except circle/half circle arc | ![]()LUMENIS® {2}------------------------------------------------ K130195 | Severe and Very Severe Non- Proliferative Diabetic Retinopathy | Panretinal Photocoagulation | Yes | All patterns except circle/half circle arc | | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----|--------------------------------------------------|--|--|--| | Macular Edema associated with Proliferative or Non-Proliferative | Focal Photocoagulation | No | Single Spot (no pattern) | | | | | Diabetic Retinopathy | Grid Photocoagulation | Yes | Square, arc, line | | | | | Retinal neovascularization associated Panretinal Photocoagulation with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) | | Yes | All patterns except circle/half circle arc | | | | | Macular Edema associated with Branch Retinal Vein Occlusion | Grid Photocoagulation | Yes | Square, arc, line | | | | | Retinal Tears and Detachments | aser Retinopexy | Yes | Circle, half circle, quarter circle | | | | | Choroidal Neovascularization | Focal Laser | No | Single Spot (no pattern) | | | | | Anterior Segment: Glaucoma | | | | | | | | Primary Open-Angle Glaucoma | Trabeculoplasty | No | Single Spot (no pattern ) | | | | | Closed Angle Glaucoma | Iridotomy | No | Single Spot (no pattern) | | | | #### VI. Substantial Equivalence Summary: The Lumenis® Array™ LaserLink™ device has equivalent intended use as the identified predicate device - Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi (#K111493), Topcon PASCAL Streamline 577 (#K111108), Topcon (OptiMedica) PASCAL Streamline Photocoagulator (#K100019); and Lumenis Vision One Laser System (#K111213), and also employs the same fundamental scientific technology as the identified predicate devices. In addition, the subject device, Lumenis® Array™ LaserLink™, and the predicate devices service similar indications for use, equivalent principles of operation, method of energy delivery, critical materials, and basal design elements when directly compared. | | | | Table 2 510(k) Summary Predicate Comparison | |--|--|--|---------------------------------------------| |--|--|--|---------------------------------------------| | | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Subject Device | |----------------------|---------------------------------|--------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------|---------------------------------------------| | Charact- eristics | K111493 Nidek MC-500 Vixi | K111108 Topcon PASCAL Streamline 577 | K100019 Topcon /OptiMedica PASCAL Streamline Photocoagulator | K111213 Lumenis Vision One Laser System | K130195 Lumenis® Array™ LaserLink™ | | Treatment λ | 532nm, 577nm, & 647nm | 577nm | 532nm | 532nm, 577nm, 659nm | 532nm, 577nm, & 659nm | Lumenis, Inc. 3959 West 1820 South Salt Lake City, Utah 84104 T. 801-656-2300 F.801−656−2415 www.lumenis.com Image /page/2/Picture/8 description: The image shows the word "LUMENIS" in a stylized font. The first two letters, "LU", are combined into a single symbol that resembles a circle with a vertical line through it. The rest of the letters are spaced out evenly and are in a bold, sans-serif font. There is a small circle above and to the right of the "S". {3}------------------------------------------------ | | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Subject Device | |-------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Charact- eristics | K111493 Nidek MC-500 Vixi | K111108 Topcon PASCAL Streamline 577 | K100019 Topcon /OptiMedica PASCAL Streamline Photocoagulator | K111213 Lumenis Vision One Laser System | K130195 Lumenis® Array™ LaserLink™ | | Laser Type | Diode Pumped Solid State | OPSL - Optically Pumped Semi- conductor Laser | OPSL - Optically Pumped Semi- conductor Laser | OPSL - Optically Pumped Semi- conductor Laser | OPSL - Optically Pumped Semi- conductor Laser | | Power Input | 100-240 VAC | 100-240 VAC | 100-240 VAC | 100-240 VAC | 100-240 VAC | | Display Type & User interface | Color LCD panel w / Touchscreen | Adjustable LCD touchscreen control panel (color) | Adjustable LCD touchscreen control panel (color) | Color LCD panel w / Touchscreen | Color LCD panel w / Touchscreen | | Compatible Lasers | Integrated: Nidek MC- 500: 532nm, 577nm, 647nm (Integrated) | Integrated: Topcon PASCAL Streamline 577: 577nm (Integrated) | Integrated: Topcon / OptiMedica PASCAL Streamline Photocoagu-lator: 532nm (Integrated) | Laser with Green (532nm), Yellow (577nm), & Red (659nm) wavelength Single spot delivery. | Non-Integrated: Lumenis Vision One: 532nm, 577nm, 659nm Lumenis Novus Spectra Family: 532nm | #### VII. Performance Data: The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted for the subject Lumenis® Array™ LaserLink™ device. IEC Testing has been completed and reports received. The Test Reports use the colloquial name of Scanning LaserLink™ rather than the determined trade name of Array™ LaserLinkTM. The subject Array™ LaserLink™ product has been subjected to outside independent laboratory testing regarding electrical safety & EMC requirements per governing IEC 60601 Series, been subjected to side-by-side comparative performance assessment to competitive products, and has undergone protocol governed verification & validation to ensure the subject product met all determined design specifications and was substantially equivalent to named predicates. As a result, Lumenis verifies that all established testing criteria and product performance specifications have been duly met, demonstrating that equivalent indications for use, safety compliance, similar design features, functional characteristics, fundamental technology features, technical applications, service similar indications for use, and general modes of operation are substantially equivalent to cited predicate devices. Lumenis, Inc. 3959 West 1820 South Salt Lake City. Utah 84104 T. 801-656-2300 F. 801-656-2415 www.lumenis.com Image /page/3/Picture/7 description: The image shows the logo for Lumenis. The logo consists of a stylized letter 'L' in a circle, followed by the word 'LUMENIS' in all capital letters. A small circle is present above and to the right of the 'S' in 'LUMENIS'. {4}------------------------------------------------ Based on the indications for use, technological characteristics, and safety and performance testing, the subject Array™ LaserLink™ product meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, technical features, service of similar indications for use, principles of operation and indications for use to current commercially available scanners/cited predicates. #### VIII. Conclusion: The Lumenis® Array™ LaserLink™ subject device has equivalent intended use, general design, and fundamental scientific technology as the predicate devices -Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi (#K111493), Topcon PASCAL Streamline 577 (#K111108), Topcon (OptiMedica) PASCAL Streamline Photocoagulator (#K100019), and Lumenis Vision One Laser System (#K111213). There are no new hazards introduced by the Lumenis® Array™ LaserLink™M device as compared with the predicate devices. Lumenis, Inc. 3959 West 1820 South Salt Lake City, Utah 84104 T. 801-656-2300 F. 801-656-2415 www.lumenis.com Image /page/4/Picture/6 description: The image shows the word "LUMENIS" in a stylized font. The first letter, "L", is part of a circular design to the left of the word. There is a small superscript symbol to the right of the "S" in "LUMENIS". {5}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 1, 2013 Lumenis, Incorporated Mr. Jace R. McLane Regulatory Affairs Specialist 3959 West 1820 South Salt Lake City, Utah 84194 Re: K130195 Trade/Device Name: Lumenis® Array" LaserLink" Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HOF Dated: October 4, 2013 Received: October 10, 2013 Dear Mr. McLane: 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {6}------------------------------------------------ Page 2 - Mr. Jace R. McLane 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, # Mark N Melkerson -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indications for Use 510(k) Number: K130195 Device Name: Lumenis® Array™ LaserLink ™ The Lumenis® Array™ LaserLink™ device is a laser system accessory intended for use in the treatment of ocular pathology. - For the posterior segment, the Lumenis® Array™ LaserLink™ device is . indicated for use in retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: o Proliferative and severe and very severe nonproliferative diabetic retinopathy o Macular edema associated with proliferative or nonproliferative diabetic retinopathy - o Choroidal neovascularization o Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion: Central retinal vein occlusion) o Macular edema associated with Branch retinal vein occlusion o Retinal tears and detachments - And anterior segments as follows: . - o Iridotomy in closed angle glaucoma - o Trabeculoplasty in open angle glaucoma The Lumenis Laser Systems compatible for connection with the Lumenis® Array™ LaserLink™ device are: - . Novus Spectra™ Laser System (K022327)(532nm) - Novus Spectra™ Dual Port Laser System (K022327)(532nm) . - Vision One™ Laser System (K111213)(532nm, 577nm, 659nm) . Page 1 of 3 {8}------------------------------------------------ | Condition | Treatment | Pattern Selection Option | Specific Pattern | |-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------|-----------------------------------------------------| | Posterior segment: Retina | | | | | Proliferative Diabetic Retinopathy | Panretinal Photocoagulation | Yes | All patterns except circle/half circle arc | | Severe and Very Severe Non- Proliferative Diabetic Retinopathy | Panretinal Photocoagulation | Yes | All patterns except circle/half circle arc | | Macular Edema associated with Proliferative or Non- Proliferative Diabetic Retinopathy | Focal Photocoagulation | No | Single Spot (no pattern) | | Macular Edema associated with Proliferative or Non- Proliferative Diabetic Retinopathy | Grid Photocoagulation | Yes | Square, arc, line | | Retinal neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) | Panretinal Photocoagulation | Yes | All patterns except circle/half circle arc | | Macular Edema associated with Branch Retinal Vein Occlusion | Grid Photocoagulation | Yes | Square, arc, line | | Retinal Tears and Detachments | Laser Retinopexy | Yes | Circle, half circle, quarter circle | | Choroidal Neovascularization | Focal Laser | No | Single Spot (no pattern) | | Anterior Segment: Glaucoma | | | | | Primary Open-Angle Glaucoma | Trabeculoplasty | No | Single Spot (no pattern) | | Closed Angle Glaucoma | Iridotomy | No | Single Spot (no pattern) | ## Table 1 Pattern Indications For Use Page 2 of ___3_ ・ . {9}------------------------------------------------ Prescription Use __XX (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) Neil R Ogden 2013.11.01 16:14:43 -04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number _K130195________________________________________________________________________________________________________________________________________________________ Page 3 of ___ 3_

SCANNING LASERLINK

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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SCANNING LASERLINK

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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