510(k) K091125 ยท ONE Powered Light Based Non-Laser Surgical Instrument
CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2
| Applicant | Verilux, South St. Paul MN, US |
| Decision | Substantially Equivalent, Sep 3, 2010 |
| Received | Apr 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091125
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.