510(k) K011197 ยท FTC Light, Ultraviolet, Dermatological
DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
| Applicant | Lumenis, Pleasanton CA, US |
| Decision | Substantially Equivalent, Dec 14, 2001 |
| Received | Apr 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011197
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.