# K032205: Radiancy Acne System with Cleartouch Light Unit Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Radiancy (Israel), Ltd.
- Decided: Dec 11, 2003 after 146 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.
175 later devices descend from it; 9 cite it directly.
0 of 176 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) ClearLight Phototherapy System, Model CT 420: named in the summary without a submission number

## Most influential descendants
- K043377: ZENO (2005), 142 descendants of its own
- K080591: Tanda Skincare System, Model: Ptscs (2008), 137 descendants of its own
- K060653: Thermaclear (2006), 132 descendants of its own
- K121435: Silkn Blue (2013), 125 descendants of its own
- K131461: Lightstim for Acne/ Lightstim for Acne Mini (2014), 81 descendants of its own

## Indications for use
The Radiancy Acne System with ClearTouch Light Unit Assembly ("Radiancy Acne System") is intended to provide phototherapeutic light to the body. The Radiancy Acne System is generally indicated to treat dermatological conditions. The Radiancy Acne System is specifically indicated to treat mild and moderate inflammatory acne which includes pustular inflammatory acne in patients with Fitzpatrick skin types I-IV.

Source page: https://510kreport.com/device/K032205
Methodology: https://510kreport.com/methodology