Solta Medical, Inc.
Bothell, WA, US
Solta Medical, Inc. appears in FDA device records in Bothell, WA. FDA records list 37 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Solta Medical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Sound Surgical Technologies, LLC510(k), recall
- Thermage, Inc.510(k), recall
510(k) clearance history
FDA records hold 37 510(k) clearances for Solta Medical, Inc. between 1999 and 2024. The busiest year on record is 2005, with 4. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 3 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 4 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242142 | Fraxel® FTX Laser System | GEX | Substantially Equivalent | |
| K223647 | CLEAR+BRILLIANT TOUCH® Laser System | GEX | Substantially Equivalent | |
| K190555 | PowerX Lipo System | QPB | Substantially Equivalent | |
| K190551 | VASERlipo System | QPB | Substantially Equivalent | |
| K173759 | Thermage CPT System and Accessories | GEI | Substantially Equivalent | |
| K170758 | Thermage FLX System and Accessories | GEI | Substantially Equivalent | |
| K132431 | THERMAGE CPT SYSTEM | GEI | Substantially Equivalent | |
| K130193 | FRAXEL DUAL 1550/1927 LASER SYSTEM | GEX | Substantially Equivalent | |
| K120328 | ORIGINS LIPOHARVESTING SYSTEM | MUU | Substantially Equivalent | |
| K121515 | ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM | ONF | Substantially Equivalent | |
| K120433 | CLEAR + BRILLIANT LASER SYSTEM | ONG | Substantially Equivalent | |
| K110306 | SOUND SURGICAL VASER 2.1 LIPO SYSTEM | QPB | Substantially Equivalent | |
| K110349 | CLEAR+BRILLIANT LASER SYSTEM | ONG | Substantially Equivalent | |
| K110255 | SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM | QPB | Substantially Equivalent | |
| K101490 | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US | ONG | Substantially Equivalent | |
| K091420 | FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 | ONG | Substantially Equivalent | |
| K090580 | THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES | GEI | Substantially Equivalent | |
| K072849 | MODIFICATION TO THERMAGE THERMACOOL SYSTEM | GEI | Substantially Equivalent | |
| K052936 | THERMAGE THERMACOOL SYSTEM | GEI | Substantially Equivalent | |
| K061001 | THERMASSAGE | GEI | Substantially Equivalent | |
| K053365 | MODIFICATION TO THERMAGE THERMACOOL SYSTEM | GEI | Substantially Equivalent | |
| K052778 | THERMAGE THERMACOOL SKIN MARKETING | GEI | Substantially Equivalent | |
| K051710 | THERMAGE THERMACOOL COUPLING FLUID | GEI | Substantially Equivalent | |
| K043402 | THERMAGE THERMACOOL SYSTEM | GEI | Substantially Equivalent | |
| K040135 | THERMAGE THERMACOOL SYSTEM | GEI | Substantially Equivalent | |
| K033942 | THERMAGE THERMACOOL SYSTEM | GEI | Substantially Equivalent | |
| K032088 | MODIFICATION TO THERMACOOL TC SYSTEM | GEI | Substantially Equivalent | |
| K031046 | THERMACOOL TC SYSTEM | GEI | Substantially Equivalent | |
| K030142 | THERMACOOL TC SYSTEM | GEI | Substantially Equivalent | |
| K021402 | THERMAGE THERMACOOL TC SYSTEM | GEI | Substantially Equivalent | |
| K022051 | SOUNDVASER SYSTEM | QPB | Substantially Equivalent | |
| K013639 | THERMAGE THERMACOOL TC SYSTEM | GEI | Substantially Equivalent | |
| K013034 | MODIFICATION TO: THERMACOOL IIA | GEI | Substantially Equivalent | |
| K003183 | THERMAGE THERMACOOL II SYSTEM | GEI | Substantially Equivalent | |
| K000944 | THERMAGE THERMACOOL SYSTEM | GEI | Substantially Equivalent | |
| K993868 | THE SOUNDVASER DISSECTION SYSTEM | LFL | Substantially Equivalent | |
| K991791 | SOUND VASER SYSTEM | LFL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011423170 | 3004106598 | Solta Medical, Inc. | 11720 N Creek Pkwy N, Bothell, WA 98011 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
- LFLInstrument, Ultrasonic Surgical
- ISAMassager, Therapeutic, Electric
- GEXPowered Laser Surgical Instrument
- ONGPowered Laser Surgical Instrument With MicrobeamFractional Output
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
- MUUSystem, Suction, Lipoplasty
- QPBSystem, Suction, Lipoplasty For Removal
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1354-2023 | 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 hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; " Non-invasive treatment of wrinkles and rhytids. The Thermage CPT System ( System ) consists of the RF Generator/ Cooling System, 16.00 cm2 Handpiece ( Body Handpiece ), Standard Handpiece with Vibration ( Face Handpiece ), optional electric Footswitch, accessory cables, Return Pad, Return Pad Cable, and Treatment Tips. | A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station. | Class II | Open, Classified | |
| Z-1681-2020 | 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 surgical procedures for electrocoagulation and hemostasis. | Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns. | Class II | Terminated | |
| Z-3048-2017 | 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 aesthetic body contouring (modification of the anatomy). | Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017. | Class II | Terminated | |
| Z-3047-2017 | 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 body contouring (modification of the anatomy). | Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017. | Class II | Terminated | |
| Z-1463-2014 | FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures. | Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma. | Class II | Terminated | |
| Z-0939-2011 | Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027 | Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed. | Terminated | ||
| Z-1010-2011 | 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-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue. | The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs. | Terminated | ||
| Z-0933-2008 | Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027. | Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed. | Terminated | ||
| Z-0556-03 | ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only | Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain