# K091125: Clearwave Phototherapy System for Acne, Model: CWST2

- Pathway: 510(k) (Traditional)
- Applicant: Verilux
- Decided: Sep 3, 2010 after 504 days
- Product code: ONE (Powered Light Based Non-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: 3 generations back to K982082 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080591: Tanda Skincare System, Model: Ptscs, Pharos Life Corporation (2008) Summary page 1.

## Indications for use
The ClearWave Phototherapy System for Acne provides phototherapeutic blue light to treat mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K091125
Methodology: https://510kreport.com/methodology