Solta Medical, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Solta Medical, Inc.” (first 2009, latest 2024), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. Since 2017 the median was 44 days, against 99 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 32 |
| 2013 | 2 | 86 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 193 |
| 2018 | 1 | 28 |
| 2019 | 2 | 57 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 23 |
| 2023 | 0 | — |
| 2024 | 1 | 30 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Solta Medical, Inc. took a median 44 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 3 | 3 |
| QPB | System, Suction, Lipoplasty For Removal | 2 | 2 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 | 1 |
Review panels
Most recent Solta Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242142 | Fraxel® FTX Laser System | GEX | 2024-08-21 | 30 |
| K223647 | CLEAR+BRILLIANT TOUCH® Laser System | GEX | 2022-12-29 | 23 |
| K190555 | PowerX Lipo System | QPB | 2019-05-01 | 57 |
| K190551 | VASERlipo System | QPB | 2019-05-01 | 57 |
| K173759 | Thermage CPT System and Accessories | GEI | 2018-01-08 | 28 |
| K170758 | Thermage FLX System and Accessories | GEI | 2017-09-22 | 193 |
| K132431 | THERMAGE CPT SYSTEM | GEI | 2013-09-06 | 32 |
| K130193 | FRAXEL DUAL 1550/1927 LASER SYSTEM | GEX | 2013-06-14 | 140 |
| K121515 | ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM | ONF | 2012-06-05 | 14 |
| K120433 | CLEAR + BRILLIANT LASER SYSTEM | ONG | 2012-04-02 | 49 |
3 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 5 recall events; 1 initiated in the last five years. Most recent: 2023-02-16.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Solta Medical, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01993238: Evaluation of Procedural Analgesia for Liposonix Treatment (Completed, started 2013-11)
- NCT01853397: Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment Method (Completed, started 2013-04)
- NCT01823653: Treatment of Subcutaneous Adipose Tissue in the Thighs Using High Intensity Focused Ultrasound (Completed, started 2012-07)
- NCT01257555: Evaluation of a Photopneumatic System for the Treatment of Acne (Completed, started 2010-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under Solta Medical, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Solta Medical, Inc.” (first 2009, latest 2024), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Solta Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Solta Medical, Inc. is 57 days. Since 2017: 44 days, versus 99 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Solta Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); GEX (Powered Laser Surgical Instrument, 3); ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output, 3).
Next steps
- See all 13 Solta Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Solta Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.