# K030508: Depilase Trio Lase Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Depilase Group, Ltd.
- Decided: May 20, 2003 after 90 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: 5 generations back to K963094 (1996). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990718: Orion Series Surgical  Laser System (SL Seriesq-Switched ND:Yag Configuration), Laserscope (2000) Summary page 2.
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration), Laserscope (2002) Summary page 2.
- K991798: Acme Medical Aesthetic ND:Yag Laser, Altus Medical (2000) Summary page 2.
- K011939: Fotona Dualis, Fotona Dualis Plus, Fotona D.D. (2001)
- K994260: Candela Gentlelase GL Dermatological Laser, Candela Corp. (2000) Summary page 2.
- K984601: Candela Gentlelase II Dermatological Laser, Candela Corp. (1999) Summary page 2.
- K992757: Cynosure Apogee-TKS Dermatological Laser, Cynosure, Inc. (2000) Summary page 2.

## Indications for use
The DEPILASE TRIO LASE Laser System is intended for the coagulation and haemostasis of vascular lesions (532 and 1064 nm), the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (755 and 1064 nm) and the dermatological applications for the non invasive treatment of facial wrinkles (1064 nm).

Source page: https://510kreport.com/device/K030508
Methodology: https://510kreport.com/methodology