LightForce LTS Model 1000, 1500, 2500, and 4000
Device Facts
| Record ID | K173067 |
|---|---|
| Device Name | LightForce LTS Model 1000, 1500, 2500, and 4000 |
| Applicant | Litecure, LLC |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Feb 22, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
810 nm and 980 nm wavelength: The LTS-1000/1500/2500/4000 devices emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle. 980 nm wavelength: The LTS-2500/4000 devices are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis. 980 nm wavelength: The LTS-2500/4000 devices are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)
Device Story
LightForce LTS (Models 1000, 1500, 2500, 4000) are diode laser systems; console assembly includes touch-screen GUI and main processor PCA. Operator selects built-in treatment protocols or adjusts optical output power and treatment times via touch panel. Laser light generated by internal module is delivered to patient via beam delivery assembly with various handpiece attachments optimized for specific indications. Used in clinical settings by healthcare professionals. Output provides topical heating for pain relief/circulation or surgical soft tissue management (hemostasis, ablation, etc.) and onychomycosis treatment. Benefits include non-invasive pain management and versatile surgical capabilities.
Clinical Evidence
Bench testing only. Verification and validation performance testing and usability testing were conducted to demonstrate system accuracy and performance. No clinical data presented.
Technological Characteristics
Diode laser system; 810 nm ± 20 nm and/or 980 nm ± 20 nm wavelengths. Console-based with touch-screen GUI. Output power up to 40W. Aiming beam: 650 nm ± 20 nm red diode laser. Connectivity: 100-240 VAC power supply. Dimensions: 41.3 cm x 26.4 cm x 25.7 cm; weight ≤10 kg. Software-controlled protocols.
Indications for Use
Indicated for patients requiring topical heating for relief of minor muscle/joint pain, stiffness, arthritis, or muscle spasm; temporary increase in local blood circulation; and muscle relaxation. Additionally, for 980 nm models, indicated for surgical soft tissue applications (hemostasis, ablation, vaporization, excision, incision, coagulation) across various medical specialties and for temporary increase of clear nail in patients with onychomycosis.
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.
Predicate Devices
- Power Medic (K070516)
- Medical Diode Laser System GBOX-15A/15B, VELAS II-60A/60B/60C (K151890)
- LiteCure Therapy System Model LTS-1500 (K123014)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration."
February 22, 2018
LiteCure, LLC Mr. Curtis Egan Principal Quality Engineer Certified Compliance Solutions, Inc. 11665 Avena Place Suite 203 San Diego, California 92128
Re: K173067
Trade/Device Name: LightForce LTS Model 1000, 1500, 2500, and 4000 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: GEX, ILY, PDZ Dated: September 27, 2017 Received: September 29, 2017
Dear Curtis Egan:
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 of medical device-related adverse events) (21 CFR 803); good
{1}------------------------------------------------
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K173067
#### Device Name
LightForce® LTS Model 1000, 1500, 2500, and 4000
#### Indications for Use (Describe)
810 nm and 980 nm wavelength:
The LTS-1000/1500/2500/4000 devices emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.
#### 980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis.
#### 980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|--|
| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for LiteCure. The logo is in blue and features the word "LITECURE" in a bold, sans-serif font. Below the word "LITECURE" is the tagline "Lasers for Life" in a smaller font. A horizontal line runs underneath the word "LITECURE" and extends to the right, ending in a starburst symbol.
250 Corporate Blvd, Suite B Newark, DE 19702
> P | 302.709.0408 F | 302.709.0409 LiteCure.com
# 510(k) Summary
| Submitter: | LiteCure, LLC. |
|-------------------------------------|-------------------------------------------------------------------------------|
| Address: | 250 Corporate Blvd. Suite B<br>Newark, DE 19702 |
| Phone Number: | (302) 709-0408 |
| FDA Registration #: | 3006268867 |
| Contact Person: | Curtis M. Egan, Principal Quality Engineer |
| Phone Number: | (951) 723 7261 |
| Fax Number: | 858-675-8201 |
| Date prepared: | February 15, 2018 |
| Trade name: | LightForce® LTS Model 1000, 1500, 2500, and 4000 |
| Common Name: | Infrared Laser |
| Classification Name: | Lamp, Infrared, Therapeutic Heating |
| Product Code: | ILY |
| Regulation: | 21 CFR 890.5500 |
| Classification Name: | Powered Laser Surgical Instrument |
| Product Code: | GEX |
| Regulation: | 21 CFR 878.4810 |
| Classification Name: | Lasers For Temporary Increase Of Clear Nail In Patients With<br>Onychomycosis |
| Product Code: | PDZ |
| Regulation: | 21 CFR 878.4810 |
| Substantial equivalence claimed to: | |
| For Product Code ILY<br>K070516 | Power Medic |
| For Product Code GEX<br>K151890 | Medical Diode Laser System GBOX-15A/15B, VELAS II-60A/60B/60C |
| For Product Code PDZ<br>K123014 | LiteCure Therapy System Model LTS-1500 |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for LiteCure. The logo is in blue and features the word "LITECURE" in a sans-serif font. Below the word is a horizontal line, and below the line is the phrase "Lasers for Life" in a smaller font. To the right of the phrase is a small asterisk.
# Description:
The LTS Product Family of devices are highly reliable, compact and easy to operate medical lasers. The Console Assembly incorporates a touch-screen display panel and a Main Processor PCA. A Software Application, executed in the Main Processor PCA, generates an intuitiye, easy to use, Graphical User Interface (GUI) and responds to operator input, via the touch panel, allowing the operator to select from build-in treatment protocols, or adjust and set the system's optical output power and treatment times with minimal effort.
Laser light generated by the Laser Module Sub-Assembly in the Console Assembly is delivered to a subject via a custom designed Beam Delivery Assembly that can be fitted with different Hand Piece Attachments. The various hand piece attachments are designed to allow the operator to deliver, indication specific optimized dose parameters (for example, onychomycosis).
# Indications for Use:
# 810 nm and 980 nm wavelength:
The LTS-1000/1500/2500/4000 devices emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.
## 980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis.
## 980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for LiteCure. The logo is in blue and consists of the word "LITECURE" in all caps, with a horizontal line underneath. Below the line, the words "Lasers for Life" are written in a smaller font. To the right of the words "Lasers for Life" is a small asterisk.
# Technological Characteristics:
The underlying technology of the LightForce® LTS Model 1000, 1500, 2500, and 4000 is the same as the predicate devices Power Medic K070516, Medical diode laser system GBOX-15A/15B, VELAS II-60A/60B/60C K151890, and LiteCure Therapy System Model LTS-1500 K123014. The system is based on the same operating principle and control, mechanism to provide the user with the same kind of information and guidance for the same Procedures. The main changes with respect to the predicate device concern the modification to the user interface, safety controls and workflow.
| General<br>Characteristic | LTS-1000 / 1500 / 2500 / 4000 | Power Medic<br>K070516 | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Indication for<br>Use | 810 nm and 980 nm wavelength:<br>The LTS-1000/1500/2500/4000 devices emit<br>energy in the visible and near infrared<br>spectrum to provide topical heating for the<br>purpose of elevating tissue temperature for a<br>temporary relief of minor muscle and joint pain<br>and stiffness, minor arthritis pain, or muscle<br>spasm; the temporary increase in local blood<br>circulation; and the temporary relaxation of<br>muscle.<br>980 nm wavelength:<br>The LTS-2500/4000 devices are also indicated<br>for use in surgical applications requiring<br>hemostasis, ablation, vaporization, excision,<br>incision, and coagulation of soft tissue in<br>medical specialties including: aesthetic<br>(dermatology and plastic surgery),<br>gastroenterology, general surgery,<br>genitourinary surgery (urology), gynecology<br>(GYN), neurosurgery, otolaryngology (ENT),<br>ophthalmology, arthroscopy, podiatry,<br>pulmonology, thoracic surgery; and Laser<br>Assisted Lipolysis.<br>980 nm wavelength:<br>The LTS-2500/4000 devices are also indicated<br>for use for the temporary increase of clear nail<br>in patients with onychomycosis (e.g.,<br>dermatophytes Trichophyton rubrum and<br>Trichophyton mentagrophytes, and/or yeasts<br>Candida albicans, etc.) | The Power Laser is intended to<br>emit energy in the visible and<br>near infrared spectrum to<br>provide topical heating for the<br>purpose of elevating tissue<br>temperature for a temporary<br>relief of minor muscle and joint<br>pain and stiffness, minor arthritis<br>pain, or muscle spasm; the<br>temporary increase in local blood<br>circulation; the temporary<br>relaxation of muscle. | |
| | Product Code | IIY | IIY |
# Table 1: Technological Characteristics Compared to Predicate Device ILY:
LiteCure, LTS System 510(k) K173067,
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image is a logo for LiteCure Lasers for Life. The logo is in blue and features the word "LITECURE" in a bold, sans-serif font. Underneath the word is the phrase "Lasers for Life" in a smaller, sans-serif font. A horizontal line extends from under the word "LITECURE" to the right, ending in a starburst symbol.
| General<br>Characteristic | LTS-1000 / 1500 / 2500 / 4000 | Power Medic<br>K070516 |
|---------------------------|-------------------------------------------------------|---------------------------------------------|
| Laser Type | Diode Laser | Diode Laser |
| Wavelength | 810 nm ± 20 nm AND/OR 980 nm ± 20 nm | 808 nm |
| Output power | 5 W at 810 nm and 20 W at 980 nm OR 25 W at<br>980 nm | 300-1500 mW |
| Dimensions | 41.3 cm (L) x 26.4 cm (W) x 25.7 cm (H) | 9 in (22.9 cm) (L) x 1.5 in (3.8 cm)<br>(W) |
| Weight | ≤10 kg | 7 oz (.2 kg) |
| Power Supply | 100-240 VAC; 50/60 Hz | Battery |
| General<br>Characteristic | LTS-1000 / 1500/ 2500 / 4000 | GBOX-15A/15B, VELASII-30A/30B,<br>VELAS II-60A/60B/60C<br>K151890 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use | 810 nm and 980 nm wavelength:<br>The LTS-1000/1500/2500/4000<br>devices emit energy in the visible and<br>near infrared spectrum to provide<br>topical heating for the purpose of<br>elevating tissue temperature for a<br>temporary relief of minor muscle and<br>joint pain and stiffness, minor arthritis<br>pain, or muscle spasm; the temporary<br>increase in local blood circulation; and<br>the temporary relaxation of muscle.<br>980 nm wavelength:<br>The LTS-2500/4000 devices are also<br>indicated for use in surgical applications<br>requiring hemostasis, ablation,<br>vaporization, excision, incision, and<br>coagulation of soft tissue in medical<br>specialties including: aesthetic<br>(dermatology and plastic surgery),<br>gastroenterology, general surgery,<br>genitourinary surgery (urology),<br>gynecology (GYN), neurosurgery,<br>otolaryngology (ENT), ophthalmology,<br>arthroscopy, podiatry, pulmonology,<br>thoracic surgery; and Laser Assisted<br>Lipolysis.<br>980 nm wavelength:<br>The LTS-2500/4000 devices are also<br>indicated for use for the temporary | The "GBOX-15A/15B" are indicated for<br>use in surgical applications requiring the<br>hemostasis, ablation, vaporization,<br>excision, incision, and coagulation of soft<br>tissue in medical specialties including:<br>aesthetic (dermatology and plastic<br>surgery), gastroenterology, general<br>surgery, genitourinary surgery<br>(urology), gynecology (GYN),<br>neurosurgery, otolaryngology (ENT),<br>ophthalmology, arthroscopy, podiatry,<br>pulmonology, and thoracic surgery; and<br>Laser Assisted Lipolysis (980 nm only).<br><br>The "VELASII-30A/30B" are indicated<br>for use in surgical applications requiring<br>the vaporization, incision, excision,<br>ablation ,cutting and hemostasis ,or<br>coagulation of soft tissue in conjunction<br>with endoscopic equipment for medical<br>specialist including: Urology (BPH),<br>Genitourinary (Urology), Thoracic<br>Surgery, Plastic Surgery and<br>Dermatology, Aesthetics including<br>vascular lesions and hair removal,<br>General Surgery, Ophthalmology,<br>Orthopedics, Podiatry, Arthroscopy,<br>Spinal Surgery, Gynecology, Pulmonary<br>Surgery. Neurosurgery (PLDD). |
| General<br>Characteristic | LTS-1000 / 1500/ 2500 / 4000 | GBOX-15A/15B, VELASII-30A/30B,<br>VELAS II-60A/60B/60C<br>K151890 |
| | increase of clear nail in patients with<br>onychomycosis (e.g., dermatophytes<br>Trichophyton rubrum and Trichophyton<br>mentagrophytes, and/or yeasts Candida<br>albicans, etc.) | Gastroenterology, Head/neck/ENT and<br>Radiology Endovascular coagulation,<br>Oral Surgery and Dental procedures,<br>laser assisted lipolysis.<br>The "VELASII-60A/60B/60C" are<br>indicated for use in surgical applications<br>requiring the vaporization, incision,<br>excision, ablation, cutting and<br>hemostasis, or coagulation of soft tissue.<br>Such as: Dermatology, Aesthetics, Plastic<br>Surgery, Vascular Surgery, Podiatry,<br>Endovenous Occlusion of the greater<br>saphenous vein of the thigh in patients<br>with superficial vein reflux. |
| Product Code | GEX | GEX |
| Laser Type | Diode Laser | Diode Laser |
| Wavelength | 810 nm ± 20 nm AND/OR 980 nm ± 20<br>nm | GBOX-15A: 810nm±10nm<br>GBOX-15B: 980nm±10nm<br>VELAS II-30A, VELAS II-60A:<br>810nm±10nm<br>VELAS II-30B, VELAS II-60B:<br>980nm±10nm<br>VELAS II-60C:<br>940nm±10nm |
| Aiming Beam | Red Diode Laser, 650 nm ± 20 nm, 3.5<br>mW ± 0.5 mW | Red Diode Laser of 635 nm, Power < 5<br>mW |
| Output Power | ≤10W ≤15W ≤25W ≤40W | 1-15 W 30 W 60 W |
| Pulse width | 250, 50, 25, 5, 2.5, 1.0, 0.5, 0.2, 0.1, 0.05<br>milliseconds, OR per Built-in Protocols | ≤2.5s |
| Repetition<br>Rate | up to 10 KHz | 0.2 Hz - 20 KHz |
| Dimensions | 41.3 cm (L) x 26.4 cm (W) x 25.7 cm (H) | 245 mm (L) x 215 mm (W) x 315 mm<br>(H) |
| Weight | ≤10 kg | 4 kg |
| General<br>Characteristic | LTS-1000 / 1500/ 2500 / 4000 | GBOX-15A/15B, VELASII-30A/30B,<br>VELAS II-60A/60B/60C<br>K151890 |
| Power Supply | 100-240 VAC; 50/60 Hz | GBOX-15A & 15B: 100-240VAC, 200VA,<br>50-60Hz |
| | | VELASII-30A, VELAS II -30B: 100-<br>240VAC, 50/60Hz, 350VA |
| | | VELAS II-60A, VELAS II-60B, VELAS II-<br>60C: 100-240VAC, 50/60Hz, 650VA |
| Power<br>Requirement | ≤400 - ≤600 VA | GBOX-15A & 15B: 100-240VAC, 200VA |
| | | VELASII-30A, VELAS II -30B:<br>350VA |
| | | VELAS II-60A, VELAS II-60B, VELAS II-<br>60C: |
| | | 650VA |
LiteCure, LTS System 510(k) K173067,
RFI 11-28-2017 Response Document 002 Page 4 of 8
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for LiteCure, a company that specializes in lasers for life. The logo is written in a blue font, with the word "LITECURE" in large letters and the tagline "Lasers for Life" in smaller letters below. A horizontal line is underneath the word "LITECURE" and extends to the right, ending in a star.
LiteCure, LTS System 510(k) K173067,
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for LiteCure. The logo is in blue and consists of the word "LITECURE" in large, bold letters. Below the word is the phrase "Lasers for Life" in a smaller font. To the right of the phrase is a small asterisk.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for LiteCure. The logo is in blue and consists of the word "LITECURE" in a sans-serif font. Below the word "LITECURE" is the phrase "Lasers for Life" in a smaller font. A horizontal line extends from under the word "LITECURE" to the right, ending in a starburst symbol.
| Table 3: Technological Characteristics Compared to Predicate Device PDZ: | | |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General<br>Characteristic | LTS-1000 / 1500/ 2500 / 4000 | LTS-1500<br>K123014 |
| Indication for<br>Use | 810 nm and 980 nm wavelength:<br>The LTS-1000/1500/2500/4000 devices emit<br>energy in the visible and near infrared<br>spectrum to provide topical heating for the<br>purpose of elevating tissue temperature for a<br>temporary relief of minor muscle and joint<br>pain and stiffness, minor arthritis pain, or<br>muscle spasm; the temporary increase in local<br>blood circulation; and the temporary<br>relaxation of muscle.<br>980 nm wavelength:<br>The LTS-2500/4000 devices are also<br>indicated for use in surgical applications<br>requiring hemostasis, ablation, vaporization,<br>excision, incision, and coagulation of soft<br>tissue in medical specialties including:<br>aesthetic (dermatology and plastic surgery),<br>gastroenterology, general surgery,<br>genitourinary surgery (urology), gynecology<br>(GYN), neurosurgery, otolaryngology (ENT),<br>ophthalmology, arthroscopy, podiatry,<br>pulmonology, thoracic surgery; and Laser<br>Assisted Lipolysis.<br>980 nm wavelength:<br>The LTS-2500/4000 devices are also<br>indicated for use for the temporary increase<br>of clear nail in patients with onychomycosis<br>(e.g., dermatophytes Trichophyton rubrum<br>and Trichophyton mentagrophytes, and/or<br>yeasts Candida albicans, etc.) | 810 nm and 980 nm:<br>LiteCure Therapy System, Model<br>LTS-1500 is indicated for emitting<br>energy in the infrared spectrum to<br>provide topical heating for the<br>purpose of elevating tissue<br>temperature for temporary relief of<br>minor muscle and joint pain, muscle<br>spasm, pain and stiffness associated<br>with arthritis and promoting<br>relaxation of the muscle tissue and<br>to temporarily increase local blood<br>circulation.<br>980 nm:<br>LiteCure Therapy System, Model<br>LTS-1500 is indicated for use for the<br>temporary increase of clear nail in<br>patients with onychomycosis (e.g.,<br>dermatophytes Trichophyton<br>rubrum and T. mentagrophytes,<br>and/or yeasts Candida albicans,<br>etc.). |
| Product Code | PDZ…
