510(k) K062963 ยท GEX Powered Laser Surgical Instrument
PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
| Applicant | Ra Medical Systems,Inc, Carlsbad CA, US |
| Decision | Substantially Equivalent, Apr 3, 2007 |
| Received | Sep 29, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062963
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2020 | Ra Medical Systems, Inc. Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototh Terminated |
GEX | None listed |
| Jul 28, 2014 | Ra Medical Systems Inc PHAROS Excimer Laser, Model No. EX-308
UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.