Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tria Beauty, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
188 daysmedian FDA review time
333 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160821 | Tria Sapphire | Tria Beauty, Inc. | 2016-06-15 | 83 | 0 |
| K141868 | TRIA FANP | Tria Beauty, Inc. | 2014-12-30 | 173 | 0 |
| K130459 | TRIA FAN SYSTEM | Tria Beauty, Inc. | 2013-10-25 | 245 | 0 |
| K120737 | TRIA LASER HAIR REMOVAL SYSTEM | Tria Beauty, Inc. | 2012-09-13 | 188 | 0 |
| K090312 | TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC | Tria Beauty, Inc. | 2010-01-05 | 333 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda