Tria Beauty, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Tria Beauty, Inc.” (first 2010, latest 2016), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 188 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 | 1 | 188 |
| 2013 | 1 | 245 |
| 2014 | 1 | 173 |
| 2015 | 0 | — |
| 2016 | 1 | 83 |
| 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 2 | 2 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 1 | 1 |
Review panels
Most recent Tria Beauty, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160821 | Tria Sapphire | OLP | 2016-06-15 | 83 |
| K141868 | TRIA FANP | ONG | 2014-12-30 | 173 |
| K130459 | TRIA FAN SYSTEM | ONG | 2013-10-25 | 245 |
| K120737 | TRIA LASER HAIR REMOVAL SYSTEM | GEX | 2012-09-13 | 188 |
| K090312 | TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC | GEX | 2010-01-05 | 333 |
Recalls
openFDA lists no recalls under a recalling firm named Tria Beauty, Inc..
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 Tria Beauty, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Tria Beauty, Inc.” (first 2010, latest 2016), across 3 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 Tria Beauty, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tria Beauty, Inc. is 188 days.
Which FDA product codes appear under Tria Beauty, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 2); ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output, 2); OLP (Over-The-Counter Powered Light Based Laser For Acne, 1).
Next steps
- See all 5 Tria Beauty, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Tria Beauty, 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.