# K252599: Diode Laser Therapy Systems (WLA-02)

- Pathway: 510(k) (Traditional)
- Applicant: Wingderm Electro-Optics, Ltd.
- Decided: Feb 24, 2026 after 190 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: 26 generations back to K943450 (1995). 577 ancestors in all.
No later device cites it as a predicate yet.
0 of 578 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222064: The Alma Soprano Titanium, Alma Lasers, Inc. (2022) Summary page 6.
- K251329: Diode laser device (RF3120-BI), Risu Medical Technology Co., Ltd. (2025) Summary page 6.
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules, Alma Lasers, Inc. (2018) Summary page 6.
- K170179: LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity, Lumenis, Ltd. (2017) Summary page 6.
- K191321: Primelase Excellence, High Technology Products S.L.U (2019) Summary page 6.

## Indications for use
The Diode Laser Therapy Systems is intended for use in dermatological procedures requiring coagulation. Indications for Use: Mixed Wavelength Handpiece (755 nm + 808 nm + 1064 nm): -Temporary hair reduction (Hair-Removal function). -Treatment of benign vascular and vascular-dependent lesions (Vascular-Lesion function). Single Wavelength Handpieces (755 nm, 808 nm, or 1064 nm): -Hair removal and permanent hair reduction in all skin types (Fitzpatrick skin types 1-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 completion of a treatment regimen.

Source page: https://510kreport.com/device/K252599
Methodology: https://510kreport.com/methodology