# K101415: Theraclear

- Pathway: 510(k) (Traditional)
- Applicant: Theravant Corporation
- Decided: Jul 8, 2010 after 49 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: 12 generations back to K910422 (1992). 82 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083730: Isolaz, Aesthera Corporation (2009) Summary page 1.

## Most influential descendants
- K123889: Acleara, Theraclear (2013), 0 descendants of its own

## Indications for use
The Theravant TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including pustular acne, comnedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all skin types (Fitzpatrick I-VI).

Source page: https://510kreport.com/device/K101415
Methodology: https://510kreport.com/methodology