Thermage, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Thermage, Inc.” (first 2000, latest 2010), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 54 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 17 | 17 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 1 | 1 |
Review panels
Most recent Thermage, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101490 | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US | ONG | 2010-09-08 | 99 |
| K072849 | MODIFICATION TO THERMAGE THERMACOOL SYSTEM | GEI | 2008-01-18 | 106 |
| K052936 | THERMAGE THERMACOOL SYSTEM | GEI | 2007-06-12 | 601 |
| K061001 | THERMASSAGE | GEI | 2006-10-12 | 184 |
| K053365 | MODIFICATION TO THERMAGE THERMACOOL SYSTEM | GEI | 2005-12-13 | 11 |
| K052778 | THERMAGE THERMACOOL SKIN MARKETING | GEI | 2005-10-20 | 17 |
| K051710 | THERMAGE THERMACOOL COUPLING FLUID | GEI | 2005-07-19 | 22 |
| K043402 | THERMAGE THERMACOOL SYSTEM | GEI | 2005-01-14 | 35 |
| K040135 | THERMAGE THERMACOOL SYSTEM | GEI | 2004-06-21 | 151 |
| K033942 | THERMAGE THERMACOOL SYSTEM | GEI | 2004-02-04 | 47 |
8 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2002-12-09.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Thermage, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Thermage, Inc.” (first 2000, latest 2010), across 2 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 Thermage, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thermage, Inc. is 54 days.
Which FDA product codes appear under Thermage, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 17); ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output, 1).
Next steps
- See all 18 Thermage, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Thermage, 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.