# K191611: Diode Laser Therapy Systems

- Pathway: 510(k) (Traditional)
- Applicant: Wingderm Electro-Optics, Ltd.
- Decided: Jul 31, 2019 after 44 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K943450 (1995). 251 ancestors in all.
No later device cites it as a predicate yet.
0 of 252 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152898: Diode Laser Therapy Systems, Beijing Sincoheren Science and Tech. Development Co., Ltd. (2016) Summary page 5.
- K141063: Linscan 808, Linscan 980, Gme (German Medical Engineering) GmbH (2014) Summary page 5.

## Recalls of this device
- Aug 23, 2024 · Class II · Z-0556-2025: All model WLA-01 systems sold to US customers are found to have labeling non-compliances

## Indications for use
The Diode Laser Therapy Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K191611
Methodology: https://510kreport.com/methodology