# K060411: Radiancy Cleartouch Lite Acne Clearance System

- Pathway: 510(k) (Traditional)
- Applicant: Radiancy (Israel), Ltd.
- Decided: Mar 22, 2006 after 34 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: 1 generation back to K032205 (2003). 2 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032205: Radiancy Acne System with Cleartouch Light Unit Assembly, Radiancy (Israel), Ltd. (2003) Summary page 2.
- K051268: Radiance Acne System with Cleartouch Light Unit, Radiancy, Ltd. (2005) Summary page 2.

## Most influential descendants
- K062048: Aesthera Photopneumatic (PPX) System (2006), 4 descendants of its own
- K083730: Isolaz (2009), 3 descendants of its own
- K080638: CLARO (2008), 2 descendants of its own
- K101415: Theraclear (2010), 1 descendant of its own
- K090744: CLARO (2010), 1 descendant of its own

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

Source page: https://510kreport.com/device/K060411
Methodology: https://510kreport.com/methodology