510(k) K222109 ยท GEX Powered Laser Surgical Instrument
Accure Laser
| Applicant | Accure Acne, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Nov 17, 2022 |
| Received | Jul 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222109
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2024 | Accure Acne, Inc Accure Laser System, Model: PFMS00004 Open, Classified |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.