Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Surgical Laser, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
152 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K843515 | MINUTEMAN CO2 MICROSURGICAL LASER GYN | American Surgical Laser, Inc. | 1985-02-04 | 152 | 0 |
| K843519 | MINUTEMAN CO2 MICROSURG LASER GEN SURG | American Surgical Laser, Inc. | 1984-12-07 | 93 | 0 |
| K843518 | MINUTEMAN C02 MICROSURG LASER PODIATRY | American Surgical Laser, Inc. | 1984-12-07 | 93 | 0 |
| K843517 | MINUTEMAN CO2 MICROSURG LASER DERMATOL- | American Surgical Laser, Inc. | 1984-12-07 | 93 | 0 |
| K843514 | MINUTEMAN CO2 MICROSURGICAL LASER OTO | American Surgical Laser, Inc. | 1984-12-04 | 90 | 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