510(k) K111172 ยท FTC Light, Ultraviolet, Dermatological
4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
| Applicant | Daavlin Distributing Co., Bryan OH, US |
| Decision | Substantially Equivalent, Aug 29, 2011 |
| Received | Apr 26, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111172
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2022 | Daavlin Distributing Company 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6. Open, Classified |
FTC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.