LINSCAN 808, LINSCAN 980

K141063 · Gme (German Medical Engineering) GmbH · GEX · Jul 15, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141063
• Device Name: LINSCAN 808, LINSCAN 980
• Applicant: Gme (German Medical Engineering) GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The GME LinScan System with the applicators LinScan 808 and LinScan 980 is indicated for hair removal and permanent hair reduction defined as the stable, longterm reduction in hair counts at 6, 9,or 12 months following a treatment regime.

Device Story

LinScan is a diode laser system for dermatological hair reduction. System comprises a base unit with touch screen controls and an applicator handpiece containing a diode laser (808 nm or 980 nm) and scanner. Operated by clinicians in a dermatological practice. Principle of operation: laser light targets hair follicle chromophores (pigment), converting light to heat to denature proteins and retard growth. Applicator features contact cooling via a sapphire window to protect skin. Output parameters (fluence, pulse duration) are user-controlled via touch screen. Device provides stable, long-term hair reduction, benefiting patients by reducing hair counts over time. No single-use parts; applicator is disinfected between patients.

Clinical Evidence

Bench testing only. Conformance to IEC 60825-1 (Laser safety) and IEC 60601-2-22 (Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment) was verified via third-party testing reports.

Technological Characteristics

Pulsed diode laser system (808 nm or 980 nm). Features include scanner-integrated applicator, sapphire contact cooling, and closed-loop water circulation system. Electrical requirements: 110-240V. User interface: touch screen. Controls: footswitch or handswitch. Beam mode: multimode. Pulse formation: CW current switched on/off. Sterilization: surface disinfection of applicator between patients.

Indications for Use

Indicated for hair removal and permanent hair reduction (stable, long-term reduction in hair counts at 6, 9, or 12 months post-treatment) in patients seeking cosmetic hair reduction.

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

• LEDA from Quantel Derma GmbH (K090762)

Submission Summary (Full Text)

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## K141063

# Section 5

# JUL 15 2014

## 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 03-08-2014 [21 CFR 807.92(a)(1)].

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

GME German Medical Engineering GmbH.

Grimmstrasse 23

Bavaria, Germany 90491

Tel: [phone]

Fax: [phone]

#### B. Contact Information

Philosopher's River IIc

P O Box 106

Willow Creek, MT 59760

Tel: [phone]

Fax: [phone]

Contact person: Mike Johnson M.D.

[e-mail]

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### K141063

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

Trade Name: LinScan 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)]

The LinScan System uses similar technology and physical output characteristics as the following predicate devices: K090762 LEDA from Quantel Derma GmbH

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

> The LinScan is a diode laser system designed to be used in Dermatological practice for stable, long term hair reduction.

The LinScan System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button), which controls an applicator unit. The applicator unit contains the diode laser and scanner. The unit comes in two models: the LinScan 808 has an applicator with a 808 nm diode laser. The LinScan 980 has an applicator with a 980 nm diode laser.

The LinScan 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 System.

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

5-2

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

The LinScan is compared to the predicate, the Quantel Derma LEDA. The indications for use and intended use for the LinScan are identical to the Quantel Derma LEDA. Below is a comparison table.

| Characteristic | GME Linscan with<br>applicators LinScan 808 and<br>LinScan 980 | Quantel Derma LEDA System<br>with applicators LEDA EPI<br>808 and LEDA EPI 980 |
|------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Applicable 510(k)s | NA | K090762 |
| Mode of Operation | Pulsed diode laser | Pulsed diode laser |
| Light Source | Laser diode | Laser diode |
| Light Delivery | Laser and scanner<br>are in the<br>Applicator<br>handpiece | Laser and scanner are in the Applicator<br>handpiece |
| Cooling of Skin | Sapphire provides<br>contact cooling. | Sapphire provides contact cooling or<br>optional air cooling. |
| Treatment Area<br>Size | 15 x 10 mm or 15<br>x 50 mm | 12 x 12 mm or 12 x 50 mm |
| Peak Power | Up to 300W | Up to 350 W |
| Fluence<br>(Energy Density<br>per Flash) | 4-100 J/cm² | 15-60 J/cm² (LEDA EPI 808)<br>15-90 J/cm² (LEDA EPI 980) |
| Pulse Widths | 4-100 ms | 6-60 ms |
| Repetition Rate | 0.5 to 2 pulses per<br>second depending<br>on energy | 0.5 to 1 pulse per second depending on<br>energy. |
| System Cooling | Self contained,<br>closed water<br>circulation system | Self contained, closed water circulation<br>system |
| Wavelength | 808 nm (LinScan<br>808)<br>980 nm (LinScan<br>980) | 808 nm (LEDA EPI 808)<br>980 nm (LEDA EPI 980) |
| Beam Mode | Multimode | Multimode |
| Beam Divergence<br>Angel | 1º Fast Axis<br>23.8° Slow Axis | Not known |
| Aiming Beam | Red aiming beam<br>laser class II | No aiming beam |
| Controls | Footswitch or<br>handswitch | Footswitch |
| Electrical<br>Requirements | 110-240 V~50<br>Hz,<br>110-230 V~60<br>Hz,<br>16 A (max. 1.75<br>kW) | 115 - 230 V ± 10% ~ 50 Hz / 60 Hz<br>10 A (max. 1.1 kW) |
| Power Calibration<br>Method | Diode current<br>calibrated by<br>external power<br>ruler | Diode current calibrated by external<br>power ruler |
| Sterilization<br>Aspects | Applicator is<br>disinfected<br>between patients. | Applicator is disinfected between<br>patients. |
| Pulse Formation | CW current<br>switched on / off | CW current switched on / off |
| Pulse Train<br>Duration | 4 ms - 100 ms | 6 ms - 60 ms |
| Beam Diameter | 1 mm x 15 mm | 1 mm x 12 mm |
| Duty Cycle | < 100% | < 100% |
| Pulse Controls | Fluence, pulse<br>duration | Fluence, pulse duration |
| Display | Touch Screen<br>Control Panel | Touch Screen Control Panel |

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

-

The GME LinScan System with the applicators LinScan 808 and LinScan 980 is indicated for hair removal and permanent hair reduction defined as the stable, longterm 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 50) June 24, 2002 was used. Third party testing reports for IEC 60825-1 and IEC 60601-2-22 were submitted.

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# K141063

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

The GME LinScan was found to be substantially equivalent to the predicate device, the LEDA from Quantel Derma, in terms of technology, function and intended use. The indications for use are identical to the previously cleared device (K090762) Quantel Derma LEDA: We believe that there are no new questions of safety or efficacy raised by the introduction of the LinScan Diode Laser System.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 15, 2014

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

Re: K141063

Trade/Device Name: GME LinScan 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 18, 2014 Received: June 26, 2014

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 (reporting of medical

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Page 2 - Mike Johnson, M.D.

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 [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (it known) K141063

### Device Name

GME LinScan System

Indications for Use (Describe)

The GME LinScan System with the applicators LinScan 980 is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9,0r 12 months following a treatment regime.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

## Neil R Ogden -S 2014.07.14 12:09:29 -04'00' For BSA

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