FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm

Gme German Medical Engineering GmbH

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

5

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K221623
Device name
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-06-06
Decision date
2023-03-10
Submission type
Traditional
Technology type
Laser fiber / delivery(AI inferred)
Clinical applications
Skin resurfacingOtherPigment treatmentAcne treatment
Primary application
Skin resurfacing
Classification source
AI classified

Indications for Use

The GME FlexSys System with module EPL 308 is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only. The GME FlexSys System with module EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only. The GME ExSys 308 System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only. The Exciplex308nm is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. The GME FlexSys System with Infrared 1550 module is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

Intended Use

The GME FlexSys System with module EPL 308 is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only. The GME FlexSys System with module EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only. The GME ExSys 308 System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only. The Exciplex308nm is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. The GME FlexSys System with Infrared 1550 module is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

Device Description

The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable. The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition, the power cord, foot switch, and the door plug are connected there. The touch-screen serves as the main control panel. The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered. The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent. During development and manufacturing applicable directives, legal requirements and standards for medical devices were considered. Our product complies to them.

Summary parsed at:2026-06-01 05:31:49 UTC

Predicate devices

5

K221623 references 5 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K221623 as a predicate