# K050950: Models Crystal 512, Record 618, Optima 518 Photo Epilation Systems

- Pathway: 510(k) (Traditional)
- Applicant: Active Optical Systems, Ltd./Efraim Bidas
- Decided: Apr 29, 2005 after 14 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: 1 generation back to K030897 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030897: Skinstation, Radiancy (Israel), Ltd. (2003) Summary page 1.
- K033549: Starlux Pulsed Light System, Palomar Medical Products, Inc. (2004) Summary page 1.

## Indications for use
The Crystal , Record & Optima are generally intended for dermatological use. The device is specifically indicated for removal of hair by using selective light energy.

Source page: https://510kreport.com/device/K050950
Methodology: https://510kreport.com/methodology