# K051671: Radiancy Skinstation with Modified Light Unit Addembly

- Pathway: 510(k) (Traditional)
- Applicant: Radiancy (Israel), Ltd.
- Decided: Sep 2, 2005 after 72 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
No predicates in its family tree.
171 later devices descend from it; 3 cite it directly.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Radiancy SkinStation Photoepilation Systems: named in the summary without a submission number
- (no number) AesThera Corporation, Model AlP: named in the summary without a submission number
- (no number) Medical Bio Care Sweden AB., ProLite: named in the summary without a submission number
- (no number) Palomar Medical Technologies, Inc., StarLux: named in the summary without a submission number

## Most influential descendants
- K053527: Spectra Hair Removal Laser (2008), 169 descendants of its own
- K082298: Flash N' GO (2008), 168 descendants of its own
- K090820: Tria Hair Removal Laser System (2009), 167 descendants of its own
- K103184: Silk'n Flash N GO (2010), 148 descendants of its own
- K103560: Shaser Ipl Hair Removal System (2011), 140 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 removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-VI.

Source page: https://510kreport.com/device/K051671
Methodology: https://510kreport.com/methodology