Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Theradome, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
262 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180460 | Theradome LH40 | Theradome, Inc. | 2018-05-18 | 87 | 0 |
| K171775 | Theradome LH80 PRO | Theradome, Inc. | 2018-01-09 | 209 | 0 |
| K161046 | Laser Helmet LH40-EVO | Theradome, Inc. | 2016-05-12 | 29 | 0 |
| K122950 | LASER HELMET | Theradome, Inc. | 2013-06-14 | 262 | 0 |
| K113097 | LASER HELMET | Theradome, Inc. | 2012-03-02 | 135 | 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