# K030506: Depilase Yag Lase Plus Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Depilase Group, Ltd.
- Decided: May 9, 2003 after 79 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 YAG LASE PLUS Laser System is intended for the coagulation and haemostasis of vascular lesions, the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and for the use in dermatological applications for the treatment of facial wrinkles

Source page: https://510kreport.com/device/K030506
Methodology: https://510kreport.com/methodology