Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Optronics Corp. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961705 | AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SY | Applied Optronics Corp. | 1996-11-01 | 183 | 0 |
| K961710 | AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SY | Applied Optronics Corp. | 1996-11-01 | 183 | 0 |
| K955007 | APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTE | Applied Optronics Corp. | 1996-01-26 | 86 | 0 |
| K955014 | APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE | Applied Optronics Corp. | 1996-01-26 | 86 | 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