TwinScan 808/755 Laser System

K192269 · Gme German Medical Engineering GmbH · GEX · Nov 19, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K192269
• Device Name: TwinScan 808/755 Laser System
• Applicant: Gme German Medical Engineering GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GME TwinScan 808/755 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. The GME TwinScan 808/755 Laser System is intended to be used on all skin types (Fitzpatrick I-VI).

Device Story

Diode laser system for dermatological hair removal/reduction. Base unit with touch screen controls applicator unit containing diode laser and scanner. Available in 808 nm or 755 nm configurations. Principle of operation: laser light absorbed by chromophores (pigment) in hair follicles; converted to heat; denatures proteins to retard growth. Used in clinical settings by trained practitioners. Cooled sapphire tip provides contact cooling during treatment. Output controlled via footswitch or handswitch. Benefits patient through stable, long-term hair reduction.

Clinical Evidence

Bench testing only. Compliance with IEC 60825-1 (laser safety), IEC 60601-2-22 (laser surgical equipment), IEC 60601-1 (general safety), and IEC 60601-1-2 (EMC) was demonstrated. No clinical data provided.

Technological Characteristics

Pulsed diode laser; 808 nm or 755 nm wavelengths; multimode beam. Contact cooling via sapphire tip. Self-contained closed-loop water cooling. 100-240V AC power. Dimensions vary by applicator (f-hp and p-hp). Controls: touch screen, footswitch/handswitch. Sterilization: manual cleaning/disinfection of applicator between patients. Standards: IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for hair removal and permanent hair reduction in patients of all skin types (Fitzpatrick I-VI).

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 Lite 808 System (K180518)
• Asclepion MeDioStar NEXT (K143519)

Submission Summary (Full Text)

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November 19, 2019

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

Re: K192269

Trade/Device Name: TwinScan 808/755 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: August 6, 2019 Received: August 21, 2019

Dear Mike 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Purva Pandva Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K192269

Device Name TwinScan 808/755 Laser System

Indications for Use (Describe)

The GME TwinScan 808/755 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.

The GME TwinScan 808/755 Laser System is intended to be used on all skin types (Fitzpatrick I-V).

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

| <span style="font-size:12pt">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------|
| <span style="font-size:12pt">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# K192269

## 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 08-08-2019 [21 CFR 807.92(a)(1)].

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

GME German Medical Engineering GmbH.

Grimmstrasse 23

Germany 90491

Tel: [phone]

Fax: [phone]

#### B. Contact Information

Philosopher's River Ilc

P O Box 106

Willow Creek, MT 59760

Tel: [phone]

Fax: [phone]

Contact person: Mike Johnson M.D.

[e-mail]

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

Trade Name: TwinScan 808/755 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

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

The TwinScan 808/755 Laser System uses similar technology and physical output characteristics as the following predicate devices: K180518 GME LinScan Lite 808 System, and K143519 Asclepion MeDioStar NEXT

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

The TwinScan 808/755 Laser System is a diode laser designed to be used in Dermatological practice for stable, long term hair reduction.

The TwinScan 808/755 Laser 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 device may be configured with 808 nm or 755 nm Applicators, in two treatment area sizes, at the factory. The TwinScan 808/755 Laser 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 TwinScan 808/755 Laser 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 (in this case, hair follicle). 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 TwinScan 808/755 Laser System is compared to the predicates

- · GME LinScan Lite 808 System K180518
- · Asclepion MeDioStar K143519

The indications for use and classification for the TwinScan 808/755 Laser System are equivalent to the predicates. Below is a comparison table of specifications.

| Characteristic | GME TwinScan 808/755<br>Laser System | GME LinScan Lite 808<br>Laser System | Asclepion MeDioStar<br>NeXT PRO XL |
|-----------------------|--------------------------------------|--------------------------------------|------------------------------------|
| | "TwinScan" | "LinScan 808" | "MeDioStar" |
| Applicable<br>510(k)s | NA | K180518 | K143519 |

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| Panel/ | General and Plastic<br>Surgery | General and Plastic Surgery | General and Plastic<br>Surgery |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code/<br>Regulation<br>Number | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 |
| Indications for<br>Use Statement | The GME TwinScan<br>808/755 Laser System is<br>indicated for hair removal<br>and permanent hair<br>reduction defined as the<br>stable, long-term reduction<br>in hair counts at 6, 9, or 12<br>months following a<br>treatment regime.<br><br>The GME TwinScan<br>808/755 Laser System is<br>intended to be used on all<br>skin types<br>(Fitzpatrick I-VI). | The GME LinScan Lite 808<br>Laser System is indicated<br>for hair removal and<br>permanent hair reduction<br>defined as the stable, long-<br>term reduction in hair counts<br>at 6, 9, or 12 months<br>following a treatment<br>regime.<br><br>The GME LinScan Lite 808<br>System is intended to be<br>used on all skin types<br>(Fitzpatrick I-VI). | The MeDioStar NeXT<br>Family laser system is<br>intended for hair removal<br>and permanent hair<br>reduction defined as<br>reduced hair growth with<br>or without maintenance<br>when measured at 6, 9 and<br>12 months.<br><br>The MeDioStar NeXT<br>Family laser system is<br>intended for the treatment<br>of benign vascular lesions.<br><br>The MeDioStar NeXT<br>Family laser system is<br>intended for the treatment<br>of benign pigmented<br>lesions. |
| Classification | Class IV | Class IV | Class IV |
| Common Name | Pulsed diode laser | Pulsed diode laser | Pulsed diode laser |
| Mechanism of<br>Action | Heats chromophores<br>(pigments) and water in the<br>skin through the absorption<br>of light. The heating<br>denatures proteins of the<br>hair follicle | Heats chromophores<br>(pigments) and water in the<br>skin through the absorption<br>of light. The heating<br>denatures proteins of the<br>hair follicle. | Heats chromophores<br>(pigments) and water in<br>the skin through the<br>absorption of light. The<br>heating denatures proteins<br>of the hair follicle. |

| Characteristic | GME TwinScan 808/755<br>Laser System<br>"TwinScan" | GME LinScan Lite<br>808<br>"LinScan Lite 808" | Asclepion MeDioStar<br>NeXT PRO XL<br>"MeDioStar" |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------|
| Applicable<br>510(k)s | NA | K180518 | K143519 |
| Mode of<br>Operation | Pulsed diode laser | Pulsed diode laser | Pulsed diode laser |
| Light Source | Laser diode | Laser diode | Laser diode |
| Light Delivery | Laser and scanner are in the<br>Applicator handpiece | Laser and scanner are in<br>the Applicator handpiece | Laser is in handpiece |
| Cooling of Skin | Sapphire provides contact<br>cooling | Sapphire provides<br>contact cooling. | Sapphire provides contact<br>cooling. |
| Treatment Area<br>Size | f-hp - applicator:<br>15 x 13 mm,<br>15 x 50 mm or 15 x 25 mm<br>p-hp - applicator:<br>10 x 25 mm, 10 x 13 mm | 10 x 25 mm, 10 x 13<br>mm | 14 x 10 mm.<br>4 x 3 mm,<br>8 x 6 mm,<br>30 x 10 mm,<br>38 x 24 mm |
| Peak Power | Up to 300 W | Up to 150W | 2400W |
| Power Density | See wavelength comparison | See wavelength<br>comparison | See wavelength comparison |
| Fluence<br>(Energy Density<br>per Flash) | See wavelength comparison | See wavelength<br>comparison | See wavelength comparison |
| Pulse Duration | 4-100ms | 4-100ms | Up to 400ms |
| Repetition Rate | up to 10 Hz | up to 2 Hz | 4 to 12 Hz |
| System Cooling | Self contained, closed water<br>circulation system | Self contained, closed<br>water circulation system | Self contained, closed<br>water circulation system |
| Wavelength | 755 nm or 808 nm | 808 nm | 755 nm, 808 nm<br>or 940 nm |
| Beam Mode | Multimode | Multimode | Multimode |
| Aiming Beam | None | None | None |
| Controls | Footswitch or handswitch | Footswitch or<br>handswitch | Footswitch or handswitch |
| Electrical<br>Requirements | 100 V-240 V @ 50/60 Hz,<br>max.1750 W | 100V-240V @ 50/60Hz,<br>max. 900W | 100 -240 VAC, 50/60 Hz,<br>max. 1500W |
| Power<br>Calibration<br>Method | Diode current calibrated by<br>external power ruler | Diode current calibrated<br>by external power ruler | Diode current calibrated by<br>external power ruler |
| Sterilization<br>Aspects | Applicator is cleaned /<br>disinfected between patients. | Applicator is cleaned /<br>disinfected between patients. | Applicator is cleaned /<br>disinfected between patients. |
| Pulse Formation | CW current switched on / off | CW current switched on / off | CW current switched on / off |
| Pulse Train<br>Duration | 4 ms – 100 ms | 4 ms – 100 ms | Up to 400 ms |
| Beam Diameter | f-hp applicator:<br>1mm x 15mm<br><br>p-hp applicator:<br>0.75 mm x 10 mm | 0.75 mm x 10 mm | 14 x 10 mm,<br>4 x 3 mm,<br>8 x 6 mm,<br>30 x 10 mm,<br>38 x 24 mm |
| Duty Cycle | < 100% | < 100% | < 100% |
| Pulse Controls | fluence, pulse duration | fluence, pulse duration | fluence, pulse duration |
| Display | Touch Screen Control Panel | Touch Screen Control Panel | Touch Screen Control Panel |

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| Characteristic | GME TwinScan<br>808/755 Laser<br>System<br>"TwinScan" | GME LinScan Lite<br>808<br>"LinScan 808" | Asclepion MeDioStar<br>NeXT PRO XL<br>"MeDioStar" |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------|
| Applicable 510(k)s | NA | K180518 | K143519 |
| 808 nm Predicate | | X | |
| 808 Beam Size | f-hp applicator:<br>1mm x 15mm (0.15 cm2)<br><br>p-hp applicator:<br>0.75 mm x 10 mm<br>(0.075 cm2) | 0.75 mm x 10 mm | NA |
| 808 Power Density | Up to 2000 W/cm² | Up to 2000 W/cm² | NA |
| 808 Treatment Area<br>Size | f-hp – 808 applicator:<br>15 x 13 mm (1.95 cm2)<br>15 x 25 mm (3.75 cm2)<br>15 x 50 mm (7.5 cm2)<br><br>p-hp - 808 applicator:<br>10 x 25 mm (2.5 cm2)<br>10 x 13 mm (1.3 cm2) | 10 x 13 mm<br>10 x 25 mm | NA |

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| 808 Peak Power | Up to 300 W | Up to 150W | NA |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|----------------------------------------------|
| 808 Fluence | 4-100 J/cm² | 4-100 J/cm² | NA |
| 755 Predicate | | NA | X |
| 755 Beam Size | f-hp applicator:<br>1mm x 15mm<br>(0.15 cm²)<br>p-hp applicator:<br>0.75 mm x 10 mm<br>(0.075 cm²) | NA | 1.4 cm² |
| 755 Power Density | f-hp = 150W/0.15cm²<br>=1000 W/cm²<br>p-hp = 75W/0.075<br>= 1000 W/cm² | NA | ALX handpiece<br>2400W/1.4cm²<br>=1714 W/cm² |
| 755 Treatment Area<br>Size | f-hp – 755 applicator:<br>15 x 13 mm (1.95 cm²)<br>15 x 25 mm (3.75 cm²)<br>15 x 50 mm (7.5 cm²)<br>p-hp - 755 applicator:<br>10 x 25 mm (2.5 cm²)<br>10 x 13 mm (1.3 cm²) | NA | 1.4 cm² |
| 755 Peak Power | Up to 150 W | NA | 2400W |
| 755 Fluence | 4-50 J/cm² | NA | Up to 35 J/cm² |

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

The GME TwinScan 808/755 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.

The GME TwinScan 808/755 Laser System is intended to be used on all skin types (Fitzpatrick I-VI).

#### 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

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IEC 60601-1-2 were also submitted.

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

The GME TwinScan 808/755 Laser System is substantially equivalent to the predicate devices, the GME LinScan Lite 808 System and Asclepion MeDioStar; in terms of technology, function and indications for use. There are no new questions of safety or efficacy raised by the introduction of the TwinScan 808/755 Laser System.