# K221623: FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm

- Pathway: 510(k) (Traditional)
- Applicant: Gme German Medical Engineering GmbH
- Decided: Mar 10, 2023 after 277 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 277 ancestors in all.
No later device cites it as a predicate yet.
0 of 278 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130193: Fraxel Dual 1550/1927 Laser System, Solta Medical, Inc. (2013) Summary page 4.
- K150752: GME ExSys 308, Gme (German Medical Engineering) GmbH (2015) Summary page 4.
- K171702: Exciplex308nm, Clarteis (2017) Summary page 4.
- K191086: Exciplex, Clarteis (2019) Summary page 4.

## Indications for use
The device FlexSys is a multi-modality skin surface treatment system. Depending on the chosen modules the intended use and the mode of operation varies. Modules UVB EPL 308 and UVB EPL 308 lite: The GME FlexSys System with module UVB EPL 308 or UVB EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only. Module Infrared 1550: 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.

Source page: https://510kreport.com/device/K221623
Methodology: https://510kreport.com/methodology