FDA applicant
Tria Beauty, Inc.
FDA records 5 decisions for Tria Beauty, Inc. (Washington D.C., DC) from 2010 to 2016: 5 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONG (Powered Laser Surgical Instrument With…). Its devices cite 18 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tria Beauty, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Tria Beauty, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report