510(k) K123494 ยท GEX Powered Laser Surgical Instrument
SOLEA
| Applicant | Convergent Dental, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Feb 11, 2013 |
| Received | Nov 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123494
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2013 | Convergent Dental Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology. Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.