# K020856: Spatouch Photoepilation System

- Pathway: 510(k) (Traditional)
- Applicant: Radiancy (Israel), Ltd.
- Decided: Jun 13, 2002 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.
198 later devices descend from it; 9 cite it directly.
0 of 199 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 (Israel) Ltd. DeLight II Hair Removal System: named in the summary without a submission number

## Most influential descendants
- K060839: Abc Hair Removal System (2006), 171 descendants of its own
- K053527: Spectra Hair Removal Laser (2008), 169 descendants of its own
- K072906: SILK'N (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

## Indications for use
The SpaTouch PhotoEpilation System is intended for removal of unwanted hair by using a selective photothermal treatment. The device is generally indicated for dermatological use. The SpaTouch is specifically indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional.

Source page: https://510kreport.com/device/K020856
Methodology: https://510kreport.com/methodology