510(k) K101490 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
| Applicant | Thermage, Inc., Hayward CA, US |
| Decision | Substantially Equivalent, Sep 8, 2010 |
| Received | Jun 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101490
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2014 | Solta Medical, Inc. FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures. Terminated |
ONG | None listed |
| 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.