# K020697: Depilase Twin Yag Laser System

- Pathway: 510(k) (Abbreviated)
- Applicant: Depilase Group, Ltd.
- Decided: Apr 12, 2002 after 39 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). 13 ancestors in all.
229 later devices descend from it; 3 cite it directly.
0 of 243 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.
- K991798: Acme Medical Aesthetic ND:Yag Laser, Altus Medical (2000) Summary page 2.
- K011939: Fotona Dualis, Fotona Dualis Plus, Fotona D.D. (2001) Summary page 2.

## Most influential descendants
- K032220: Adept 1064/532 Laser (2003), 126 descendants of its own
- K032218: Adept 1064/532/755 Laser (2003), 104 descendants of its own
- K083207: Ultrawave Iii EX 1320 (2008), 96 descendants of its own
- K062369: Iridex Oculight TX (2006), 73 descendants of its own
- K091534: Lightlas Model 532 (2009), 72 descendants of its own

## Indications for use
The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions (1064 and 532 nm wavelengths) and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I —VI, including suntanned skin types (1064 nm wavelength).

Source page: https://510kreport.com/device/K020697
Methodology: https://510kreport.com/methodology