Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Laser Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
90 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010046 | NUVOLASE 532 MEDICAL LASER SYSTEM | American Laser Corp. | 2001-04-05 | 90 | 0 |
| K990665 | BQ/BM INTEGRATED LASER DELIVERY SYSTEM | American Laser Corp. | 1999-05-17 | 76 | 0 |
| K990725 | NUVOLASE 532 LASER SYSTEM | American Laser Corp. | 1999-03-22 | 17 | 0 |
| K827819 | LASER PHOTOCOAGULATOR | American Laser Corp. | 1983-01-07 | 80 | 0 |
| K813429 | LASER PHOTOCOAGULATOR ARGON MED. LASER | American Laser Corp. | 1982-01-22 | 45 | 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