# K060653: Thermaclear

- Pathway: 510(k) (Traditional)
- Applicant: Dermacare, Inc.
- Decided: Oct 24, 2006 after 225 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: 2 generations back to K982082 (1998). 4 ancestors in all.
132 later devices descend from it; 5 cite it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043377: ZENO, Tyrell, Inc. (2005) Summary page 1.
- K032205: Radiancy Acne System with Cleartouch Light Unit Assembly, Radiancy (Israel), Ltd. (2003) Summary page 1.

## Most influential descendants
- K121435: Silkn Blue (2013), 125 descendants of its own
- K131461: Lightstim for Acne/ Lightstim for Acne Mini (2014), 81 descendants of its own
- K162098: LED Phototherapy Device (2017), 75 descendants of its own
- K171821: 2 Face / Face Evolution (2018), 58 descendants of its own
- K142246: LightStim for Acne/ LightStim for Acne Mini (2015), 55 descendants of its own

## Indications for use
ThermaClear is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K060653
Methodology: https://510kreport.com/methodology