# K052442: Radiancy Skinstation with Psoriasis Light Unit Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Radiancy (Israel), Ltd.
- Decided: Jan 26, 2006 after 142 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: 9 generations back to K910422 (1992). 67 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050047: Cutera Optional Pulsed Light Hand Piece Family, Cutera, Inc. (2005) Summary page 2.
- (no number) Radiancy SkinStation Systems: named in the summary without a submission number
- (no number) Cooltouch Prima IPL system: named in the summary without a submission number
- (no number) Candela, Inc. C-Beam dye laser: named in the summary without a submission number
- (no number) Lumenis, Inc., BClear lamp: named in the summary without a submission number
- (no number) CureLight, Ltd., MultiClear lamp: named in the summary without a submission number
- (no number) MSQ ("M2") Ltd. Lovely II IPL UV lamp: named in the summary without a submission number

## Most influential descendants
- K072331: Radiancy Mistral Device (2008), 6 descendants of its own
- K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C (2009), 4 descendants of its own
- K062048: Aesthera Photopneumatic (PPX) System (2006), 4 descendants of its own
- K083730: Isolaz (2009), 3 descendants of its own
- K102857: Ahwon's Ipl System (2011), 2 descendants of its own

## Indications for use
The SkinStation® is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, in patients with Fitzpatrick skin types I-VI, and mild to moderate psoriasis in patients with Fitzpatrick skin types I-VI.

Source page: https://510kreport.com/device/K052442
Methodology: https://510kreport.com/methodology