# K052991: Radiancy Facial Skincare Device

- Pathway: 510(k) (Traditional)
- Applicant: Radiancy (Israel), Ltd.
- Decided: Feb 1, 2006 after 99 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: 8 generations back to K910422 (1992). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033181: SPR System, Radiancy (Israel), Ltd. (2003) Summary page 2.
- K043255: Ellipse Light SPT, Danish Dermatologic Development A/S (2005) Summary page 2.

## Indications for use
The Radiancy Facial SkinCare Device is intended for dermatological use. The Facial SkinCare Device is specifically intended to treat benign pigmented lesions, including, but not limited to solar lentigines, ephilides (freckles), and mottled pigmentation in patients with Fitzpatrick skin types I-V.

Source page: https://510kreport.com/device/K052991
Methodology: https://510kreport.com/methodology