Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reliant Laser Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950215 | ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HA | Reliant Laser Corp. | 1995-06-15 | 147 | 0 |
| K942868 | ACUTOME 2000 COLOR-CORRECTED LAPAROSCOPIC C02 LASER COUPLER | Reliant Laser Corp. | 1994-11-14 | 150 | 0 |
| K920821 | UNIMAX MODEL 2000 COLOR-CORRECTED MICROSPOT CO2 | Reliant Laser Corp. | 1992-05-21 | 87 | 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