Company · US
Solta Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2024. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 21, 2024 | K242142 | Fraxel® FTX Laser System Solta Medical | GEX |
| Dec 29, 2022 | K223647 | CLEAR+BRILLIANT TOUCH® Laser System Solta Medical, Inc. | GEX |
| May 1, 2019 | K190555 | PowerX Lipo System Solta Medical | QPB |
| May 1, 2019 | K190551 | VASERlipo System Solta Medical | QPB |
| Jan 8, 2018 | K173759 | Thermage CPT System and Accessories Solta Medical | GEI |
| Sep 22, 2017 | K170758 | Thermage FLX System and Accessories Solta Medical | GEI |
| Sep 6, 2013 | K132431 | THERMAGE CPT SYSTEM Solta Medical, Inc. | GEI |
| Jun 14, 2013 | K130193 | FRAXEL DUAL 1550/1927 LASER SYSTEM Solta Medical, Inc. | GEX |
| Jun 5, 2012 | K121515 | ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM Solta Medical, Inc. | ONF |
| Apr 2, 2012 | K120433 | CLEAR + BRILLIANT LASER SYSTEM Solta Medical, Inc. | ONG |
| May 3, 2011 | K110349 | CLEAR+BRILLIANT LASER SYSTEM Solta Medical, Inc. | ONG |
| Oct 14, 2009 | K091420 | FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 Solta Medical, Inc. | ONG |
| Jun 26, 2009 | K090580 | THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES Solta Medical, Inc. | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2023 | Solta Medical Inc thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc.
thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc.
Dermatologic and general surgical procedures for electrocoagulation and hemosta Open, Classified |
GEI | K173759 |
| Dec 30, 2019 | Solta Medical Inc Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgic Terminated |
GEI | K132431 |
| Jun 1, 2017 | Solta Medical Inc VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA
The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for ae Terminated |
None listed | |
| Jun 1, 2017 | Solta Medical Inc VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA
The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic b Terminated |
K110306 | |
| Apr 16, 2014 | Solta Medical, Inc. FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures. Terminated |
ONG | K101490 |
| 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 | K091420 K101490 |