# K203054: FlexSys

- Pathway: 510(k) (Traditional)
- Applicant: Gme German Medical Engineering GmbH
- Decided: Mar 5, 2021 after 149 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: 10 generations back to K943450 (1995). 100 ancestors in all.
No later device cites it as a predicate yet.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031425: Gentlewaves Led Photomodulation Device, Light Bioscience, LLC (2004) Summary page 4.
- K120460: Smartlux, Medmix Co., Ltd. (2012) Summary page 4.
- K133297: Quadrostarprogreen, Quadrostarproyellow, Asclepion Laser Technologies GmbH (2014) Summary page 4.

## Indications for use
The device FlexSys is a multi-modality skin surface treatment. Depending on the chosen modules the intended use and the mode of operation varies. Module MultiLite: The intended use of the device FlexSys with MultiLite module is: * Blue 420 nm light: The GME FlexSys with Blue 420 MultiLite is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. * Yellow 585 nm light: The GME FlexSys with module Yellow 585 is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. * Red 635 nm Light: The GME FlexSys with Red 635 MultiLite is indicated in general to treat dermatological conditions and specifically indicated to treat superficial, benign vascular, and pigmented lesions. Module Green 532: The GME FlexSys with module Green 532 (wavelength: 532nm) is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissue. Module Yellow 577: The GME FlexSys with module Yellow 577 (wavelength: 577nm) is intended for treatment of benign vascular and benign pigmented lesions.

Source page: https://510kreport.com/device/K203054
Methodology: https://510kreport.com/methodology