# K020412: Depilase Twin Lase Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Depilase Group, Ltd.
- Decided: Feb 22, 2002 after 15 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). 19 ancestors in all.
106 later devices descend from it; 2 cite it directly.
0 of 126 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.
- 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.

## Most influential descendants
- K032218: Adept 1064/532/755 Laser (2003), 104 descendants of its own
- K083207: Ultrawave Iii EX 1320 (2008), 96 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own
- K123168: Q-Plus T+ Ipl Laser System (2012), 40 descendants of its own
- K130256: MDK Multi-Applications Platform (2013), 38 descendants of its own

## Indications for use
The DEPILASE TWIN LASE Laser System is intended for the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I VI, including suntanned skin types.

Source page: https://510kreport.com/device/K020412
Methodology: https://510kreport.com/methodology