# K030897: Skinstation

- Pathway: 510(k) (Traditional)
- Applicant: Radiancy (Israel), Ltd.
- Decided: Jun 19, 2003 after 90 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.
222 later devices descend from it; 10 cite it directly.
0 of 223 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’s SpaTouch Hair Removal System: named in the summary without a submission number
- (no number) Lumenis IPL Quantum SR: named in the summary without a submission number
- (no number) Medical Bio Care Sweden’s Prolite: named in the summary without a submission number
- (no number) Palomar’s EsteLux: 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 a pulsed light device intended for hair removal and for treatment of pigmented and vascular lesions.

Source page: https://510kreport.com/device/K030897
Methodology: https://510kreport.com/methodology