Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Lasers, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
186 daysmedian FDA review time
279 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061850 | MINI-YAG LASER | American Lasers, Inc. | 2006-09-29 | 91 | 0 |
| K974142 | HM-RUBY | American Lasers, Inc. | 1998-01-28 | 86 | 0 |
| K970475 | MM-RUBY | American Lasers, Inc. | 1997-09-29 | 234 | 0 |
| K950826 | AM RUBY | American Lasers, Inc. | 1995-11-29 | 279 | 0 |
| K950825 | AM-YAG | American Lasers, Inc. | 1995-08-28 | 186 | 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