Data / Medical devices / United States / Solta Medical, Inc.
Solta Medical, Inc.: FDA-registered device maker in Bothell, WA, United States, 25 510(k) clearances
Solta Medical, Inc. is registered with the FDA (registration 3011423170) in Bothell, WA, United States. It lists 8 device types. The FDA files 25 510(k) clearances under its listings, the newest dated August 21, 2024. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011423170
- FEI number
- 3004106598
- Address
- 11720 N Creek Pkwy N Suite 100, Bothell, WA, United States, 98011
- Owner or operator
- Solta Medical (9042311)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 11, 2009
- Registered through
- 2026
- Brand names listed
- Clear+Brilliant Laser System, Clear+Brilliant TOUCH, Fraxel re:store DUAL Laser System, Liposonix System Model 1, Permea, PowerX Lipo System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | OHV | 2 | Complaint file establishment | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| System, Suction, Lipoplasty | MUU | 2 | Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Suction, Lipoplasty For Removal | QPB | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2024 | K242142 | Fraxel® FTX Laser System | GEX | Substantially Equivalent | Solta Medical | accessdata.fda.gov |
| December 29, 2022 | K223647 | CLEAR+BRILLIANT TOUCH® Laser System | GEX | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| May 1, 2019 | K190555 | PowerX Lipo System | QPB | Substantially Equivalent | Solta Medical | accessdata.fda.gov |
| May 1, 2019 | K190551 | VASERlipo System | QPB | Substantially Equivalent | Solta Medical | accessdata.fda.gov |
| September 22, 2017 | K170758 | Thermage FLX System and Accessories | GEI | Substantially Equivalent | Solta Medical | accessdata.fda.gov |
| July 15, 2014 | K141063 | LINSCAN 808, LINSCAN 980 | GEX | Substantially Equivalent | Gme (German Medical Engineering) GmbH | accessdata.fda.gov |
| September 6, 2013 | K132431 | THERMAGE CPT SYSTEM | GEI | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| June 14, 2013 | K130193 | FRAXEL DUAL 1550/1927 LASER SYSTEM | GEX | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| September 17, 2012 | K120328 | ORIGINS LIPOHARVESTING SYSTEM | MUU | Substantially Equivalent | Sound Surgical Technologies, LLC | accessdata.fda.gov |
| June 5, 2012 | K121515 | ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM | ONF | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| April 2, 2012 | K120433 | CLEAR + BRILLIANT LASER SYSTEM | ONG | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| March 7, 2012 | K113255 | PUREGRAFT 850/PURE SYSTEM | MUU | Substantially Equivalent | Cytori Therapeutics, Inc. | accessdata.fda.gov |
| August 19, 2011 | K100874 | LIPOSONIX SYSTEM, MODEL 1 P00XXXX | OHV | Substantially Equivalent | Medicis Technologies Corporation | accessdata.fda.gov |
| June 23, 2011 | K110306 | SOUND SURGICAL VASER 2.1 LIPO SYSTEM | QPB | Substantially Equivalent | Sound Surgical Technologies, LLC | accessdata.fda.gov |
| May 3, 2011 | K110349 | CLEAR+BRILLIANT LASER SYSTEM | ONG | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| April 4, 2011 | K110255 | SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM | QPB | Substantially Equivalent | Sound Surgical Technologies, LLC | accessdata.fda.gov |
| September 8, 2010 | K101490 | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US | ONG | Substantially Equivalent | Thermage, Inc. | accessdata.fda.gov |
| January 6, 2010 | K092923 | CYTORI PUREGRAFT 250/PURE SYSTEM | MUU | Substantially Equivalent | Cytori Therapeutics, Inc. | accessdata.fda.gov |
| October 14, 2009 | K091420 | FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 | ONG | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| June 26, 2009 | K090580 | THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES | GEI | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| January 9, 2009 | K083730 | ISOLAZ | GEX | Substantially Equivalent | Aesthera Corporation | accessdata.fda.gov |
| July 1, 2008 | K080915 | FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES | GEX | Substantially Equivalent | Reliant Technologies, Inc. | accessdata.fda.gov |
| November 2, 2007 | K071051 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | GEX | Substantially Equivalent | Reliant Technologies, Inc. | accessdata.fda.gov |
| May 17, 2007 | K070284 | FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) | GEX | Substantially Equivalent | Reliant Technologies, Inc. | accessdata.fda.gov |
| April 27, 2007 | K063038 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | GEX | Substantially Equivalent | Reliant Technologies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 16, 2023 | 91847 | Class II | Ongoing | 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 tr | A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station. | accessdata.fda.gov |
| December 30, 2019 | 85314 | Class II | Terminated | 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 ele | 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. | accessdata.fda.gov |
| June 1, 2017 | 77655 | Class II | Terminated | 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 (modific | 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. | accessdata.fda.gov |
| December 21, 2010 | 57630 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
| December 28, 2007 | 46293 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Suction, Lipoplasty For Removal
- All makers of Powered Laser Surgical Instrument
- All makers of System, Suction, Lipoplasty
- All makers of Massager, Therapeutic, Electric
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
Updated August 21, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.