510(k) K091420 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500
| Applicant | Solta Medical, Inc., Haywood CA, US |
| Decision | Substantially Equivalent, Oct 14, 2009 |
| Received | May 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2011 | Solta Medical, Inc. Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology.
Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500 Terminated |
ONG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.