Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Laser Medical · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
90 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990780 | NUVOLASE 532 CUTANEOUS LASER SYSTEM | American Laser Medical | 1999-03-22 | 13 | 0 |
| K972765 | NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER | American Laser Medical | 1997-10-21 | 89 | 0 |
| K972561 | NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY | American Laser Medical | 1997-10-06 | 89 | 0 |
| K970667 | NUVO-LASE 660 LASER SYSTEM | American Laser Medical | 1997-05-13 | 78 | 0 |
| K963389 | FLEX-LASE 600 SERIES ION LASER SYSTEM | American Laser Medical | 1996-11-26 | 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