# K030510: Depilase Twin Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Depilase Group, Ltd.
- Decided: May 14, 2003 after 84 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: 2 generations back to K000811 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration), Laserscope (2002) Summary page 2.

## Indications for use
The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions (1064 and 532 nm wavelengths), the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and the dermatological use for the non invasive treatment of facial wrinkles (1064 nm wavelength).

Source page: https://510kreport.com/device/K030510
Methodology: https://510kreport.com/methodology