GME LinScan Lite 808 Laser System

K180518 · Gme German Medical Engineering GmbH · GEX · Jul 23, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180518
• Device Name: GME LinScan Lite 808 Laser System
• Applicant: Gme German Medical Engineering GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GME LinScan Lite 808 Laser System is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9,or 12 months following a treatment regime.

Device Story

Diode laser system for dermatological hair removal/reduction; base unit with touch screen controls applicator containing laser and scanner. Principle: laser light absorbed by hair follicle chromophores (pigment) converts to heat, denaturing proteins to retard growth. Used in clinical settings by trained professionals. Cooled sapphire tip provides contact cooling to skin during treatment. Output: pulsed laser energy (808 nm). Healthcare provider adjusts fluence and pulse duration via touch screen; output affects hair follicle viability. Benefits patient via stable, long-term hair reduction.

Clinical Evidence

Bench testing only. Compliance with IEC 60825-1 (Laser safety), IEC 60601-2-22 (Laser surgical instruments), and IEC 60601-1 (General safety) standards was demonstrated.

Technological Characteristics

Pulsed diode laser (808 nm); sapphire contact cooling; 13x10 mm or 25x10 mm treatment area; 4-100 J/cm² fluence; 4-100 ms pulse width; up to 2Hz repetition rate; 150W peak power. Self-contained closed-loop water cooling. Touch screen interface. Electrical: 100V-240V. No single-use parts; applicator cleaned between patients.

Indications for Use

Indicated for hair removal and permanent hair reduction in patients seeking stable, long-term reduction in hair counts.

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

• GME LinScan 808/980 System (K141063)

Submission Summary (Full Text)

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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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 23, 2018

GME German Medical Engineering GmbH % Mike Johnson Consultant Philosopher's River LLC P O Box 106 Willow Creek, Montana 59760

Re: K180518

Trade/Device Name: GME LinScan Lite 808 Laser System 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: June 11, 2018 Received: June 21, 2018

Dear Dr. Johnson:

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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# David Krause -S

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

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K180518

# Section 4

### Indications for Use

510(k) Number (if known): __NA________________________________________________________________________________________________________________________________________________

Device Name: GME LinScan Lite 808 Laser System

Indications for Use:

The GME LinScan Lite 808 Laser System is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9,or 12 months following a treatment regime.

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X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

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# Section 5

### 510(k) Summarv

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 07-18-2018 [21 CFR 807.92(a)(1)].

#### A. Applicant Name and Address [21 CFR 807.92(a)(1)]

GME German Medical Engineering GmbH.

Grimmstrasse 23

Bavaria, Germany 90491

Tel: [phone]

Fax: [phone]

#### B. Contact Information

Philosopher's River llc

P O Box 106

Willow Creek, MT 59760

Tel: [phone]

Fax: [phone]

Contact person: Mike Johnson M.D.

mike(@)philosophersriver.com

#### C. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name: LinScan Lite 808 Laser System Device Common Name: Laser Instrument for Dermatology Classification Name: Laser Instrument, Surgical Powered 21 CFR 878.4810 Product Code: GEX Device Classification: Class II

#### D. Predicate Devices [21 CFR 807.92(a)(3)]

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The LinScan Lite 808 Laser System uses similar technology and physical output characteristics as the following predicate device: K141063 GME LinScan 808/980 Svstem

#### E. Device Description [21 CFR 807.92(a)(4)]

The LinScan Lite 808 Laser System is a diode laser designed to be used in Dermatological practice for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.

The LinScan Lite 808 System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button) that controls an applicator unit. The applicator unit contains the diode laser and scanner.

The LinScan Lite 808 System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit.

A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the LinScan Lite 808 System.

Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The heat denatures the protein of the chromophore. Specifically, the hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.

#### F. Device Specifications and Comparison to Predicates [21 CFR 807.92(a)(6)]

The GME LinScan Lite 808 System is compared to the predicates • GME LinScan 808/980 System K141063

The indications for use and classification for the LinScan Lite 808 System are equivalent to the predicate. Below is a comparison table.

| Characteristic | GME LinScan Lite 808 Laser<br>System | GME LinScan 808 and LinScan 980 |
|------------------------------------|--------------------------------------|---------------------------------|
| | "LinScan Lite" | "LinScan 808/980" |
| Applicable 510(k)s | NA | K141063 |
| Panel/ | General and Plastic Surgery | General and Plastic Surgery |
| Product Code/<br>Regulation Number | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 |

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| Indications for Use Statement | The GME LinScan Lite<br>808System is indicated for hair<br>removal and permanent hair<br>reduction defined as the stable,<br>long-term reduction in hair counts<br>at 6, 9,or 12 months following a<br>treatment regime. | The GME LinScan System with the<br>applicators LinScan 808 and LinScan<br>980 is indicated for hair removal and<br>permanent hair reduction defined as the<br>stable, long-term reduction in hair<br>counts at 6, 9,or 12 months following a<br>treatment regime. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class IV | Class IV |
| Common Name | Pulsed diode laser | Pulsed diode laser |
| Mechanism of Action | Heats chromophores (pigments)<br>and water in the skin through the<br>absorption of light. The heating<br>denatures proteins of the hair<br>follicle. | Heats chromophores (pigments) and<br>water in the skin through the absorption<br>of light. The heating denatures proteins<br>of the hair follicle. |

The specifications for the LinScan Lite 808 System are equivalent to the predicates.
Below is a comparison table.

| Characteristic | GME LinScan<br>Lite 808 Laser System<br><br>"LinScan Lite" | GME LinScan 808 and LinScan<br>980<br><br>"LinScan 808/980" |
|---------------------------------------|------------------------------------------------------------|-------------------------------------------------------------|
| Applicable 510(k)s | NA | K141063 |
| Mode of Operation | Pulsed diode laser | Pulsed diode laser |
| Light Source | Laser diode | Laser diode |
| Light Delivery | Laser and scanner are in the<br>Applicator handpiece | Laser and scanner are in the Applicator<br>handpiece |
| Cooling of Skin | Sapphire provides contact cooling. | Sapphire provides contact cooling. |
| Treatment Area Size | 13 x 10 mm<br>25 x 10 mm, | 15 x 10 mm,<br>15 x 50 mm |
| Peak Power | Up to 150 W | Up to 300W |
| Power Density | 2000 W/cm2 | 2000 W/cm2 |
| Fluence<br>(Energy Density per Flash) | 4-100 J/cm² | 4-100 J/cm² |
| Pulse Widths | 4-100 ms | 4-100 ms |
| Repetition Rate | up to 2Hz | up to 2Hz |
| System Cooling | Self contained, closed water<br>circulation system | Self contained, closed water circulation<br>system |
| Wavelength | 808 nm Applicator. | 808 nm or<br>980 nm Applicator |
| Beam Mode | Multimode | Multimode |
| Aiming Beam | None | Red aiming beam laser class II |
| Controls | Footswitch or handswitch | Footswitch or handswitch |
| Electrical Requirements | 100V-240V @ 50/60Hz, max. 900W | 110V-240V at 50Hz, 110V-220V at<br>60Hz, max. 1750W |
| Power Calibration Method | Diode current calibrated by external<br>power ruler | Diode current calibrated by external<br>power ruler |
| Sterilization Aspects | Applicator is cleaned between<br>patients. | Applicator is cleaned between patients. |
| Pulse Formation | CW current switched on / off | CW current switched on / off |
| Pulse Duration | 4 ms - 100 ms | 4 ms - 100 ms |
| Beam Diameter | 0.75 mm x 10 mm | 1 mm x 15 mm |
| Duty Cycle | < 100% | < 100% |
| Pulse Controls | Fluence, pulse duration | Fluence, pulse duration |
| Display | Touch Screen Control Panel | Touch Screen Control Panel |

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#### G. Indications for Use [21 CFR 807.92(a)(5)]

The GME LinScan Lite 808 System is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9,or 12 months following a treatment regime.

#### H. Performance Data [21 CFR 807.92(b)(2)]

The Guidance Document, Laser Products – Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice 56) January 19, 2018 was used. Testing reports for IEC 60825-1 and IEC 60601-2-22 were submitted. Testing reports for IEC 60601-1 and IEC 60601-2 were also submitted.

#### I. Conclusion [21 CFR 807.92(b)(3)]

The GME LinScan Lite 808 Laser System is substantially equivalent to the predicate device, the GME LinScan 808/980 System; in terms of technology, function and indications for use. There are no new questions of safety or efficacy raised by the introduction of the LinScan Lite 808 Diode Laser System.