Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Freedom Laser Therapy, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222081 | ID-510 iRestore Elite | Freedom Laser Therapy, Inc. | 2022-10-13 | 90 | 0 |
| K213094 | ID-500 iRestore Hair Growth System | Freedom Laser Therapy, Inc. | 2021-12-22 | 89 | 0 |
| K183417 | iRestore Professional 282 | Freedom Laser Therapy, Inc. | 2019-05-17 | 158 | 0 |
| K151662 | iRestore | Freedom Laser Therapy, Inc. | 2016-01-06 | 201 | 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