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Sign in to claim this brandSolta Medical, Inc.
United States·US-MF-000018343
Last updated September 17, 2026
What Solta Medical, Inc. makes
Solta Medical, Inc. manufactures liposuction systems and cannulas, ultrasonic surgical system generators, multi-modality skin surface treatment systems, dermatological laser beam guiding handpieces, radio-frequency skin contouring system applicator tips, ultrasonic skin/body contouring systems, and electrical foot-switches.
The company's portfolio includes devices classified as Class I, Class II, Class IIa, and Class IIb, and is listed in both eudamed and fda_udi registries. Solta Medical is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Solta Medical, Inc. manufacture?
Solta Medical, Inc. manufactures liposuction systems and cannulas, ultrasonic surgical system generators, multi-modality skin surface treatment systems, dermatological laser beam guiding handpieces, radio-frequency skin contouring system applicator tips, ultrasonic skin/body contouring systems, and electrical foot-switches.
Where is Solta Medical, Inc. based?
Solta Medical, Inc. is based in the United States, as indicated by the country information provided in the device data.
Which regulatory registries list Solta Medical's devices?
Solta Medical's devices are listed in both the eudamed and fda_udi registries, as specified in the device data provided.
How are Solta Medical's devices classified?
Solta Medical's devices are classified as Class I, Class II, Class IIa, and Class IIb, with the most common categories being liposuction system cannula, reusable, liposuction system, and ultrasonic surgical system generator.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 11720 North Creek Parkway N. Suite 100, Bothell, United States
- Website
- solta.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Sophie Xu
- EUDAMED SRN
- US-MF-000018343
- FDA FEI Number
- 3004106598
- DUNS Number
- —
Catalogue (413)
Page 9 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Thermage FLX Body Tip, 16.00 cm2, 500 REP | TT16.00F6-500 | EUDAMEDFDA UDI | Class I | Active |
| Powerx Footswitch | 120-0053 | EUDAMEDFDA UDI | Class I | Active |
| Thermage Marking Paper, 16.00cm2 | SM-16.00 | EUDAMEDFDA UDI | Class I | Active |
| Vaser Rf Wireless Footswitch | P010338 | EUDAMEDFDA UDI | Class I | Active |
| Ventx Footswitch | 120-0049 | EUDAMEDFDA UDI | Class I | Active |
| Thermage Marking Paper, 16cm2 | TK-16.00 | EUDAMEDFDA UDI | Class I | Active |
| Thermage Coupling Fluid, 30ml | TF-2-30 | EUDAMEDFDA UDI | Class I | Active |
| Thermage Marking Paper, 3.00cm2 Large | TK-3.00-L | EUDAMEDFDA UDI | Class I | Active |
| Thermage FLX Total Tip, 3.00 cm2, 450 REP | TT3.00F6-400 | EUDAMEDFDA UDI | Class I | Active |
| Thermage FLX System - Refurbished | TG-3AR | EUDAMEDFDA UDI | Class I | Active |
| Thermage Marking Paper, 3.00cm2 - Large | SM-3.00-L | EUDAMEDFDA UDI | Class I | Active |
| Footswitch | TW-2 | EUDAMEDFDA UDI | Class I | Active |
| Thermage FLX Eye Tip, 0.25 cm2, 450 REP | TT0.25F6-450 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Solta Medical, Inc. has 6 recall records initiated between 2010-12-15 and 2023-02-16, with statuses recorded as open, classified, and terminated. The reasons given include obsolete versions of the Laser Treatment Settings card containing incorrect indications, a service unit potentially improperly tested and calibrated, potential for inadvertent laser firing, potential inaccurate calibration by service depot repair, and complaints of sparking of electrosurgical device tips.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 16, 2023 | Z-1354-2023 | — | open, classified | A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station. |
| Dec 30, 2019 | Z-1681-2020 | — | terminated | 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. |
| Jun 1, 2017 | Z-3048-2017 | — | terminated | 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. |
| Jun 1, 2017 | Z-3047-2017 | — | terminated | 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. |
| Mar 20, 2014 | Z-1463-2014 | — | terminated | 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. |
| Dec 15, 2010 | Z-1010-2011 | — | terminated | The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs. |