510(k) K100378 ยท FTC Light, Ultraviolet, Dermatological
1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
| Applicant | Daavlin Distributing Co., Bryan OH, US |
| Decision | Substantially Equivalent, Apr 28, 2010 |
| Received | Feb 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100378
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2022 | Daavlin Distributing Company 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6],
[1 Ser CX 311-4 120 Open, Classified |
FTC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.