Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coherent Radiation Laboratories · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K837235 | MODEL 920 ARGON LASER SYSTEM | Coherent Radiation Laboratories | 1983-04-04 | 34 | 0 |
| K837125 | SYSTEM 900 TWO ROOM REMOTE FIBERS | Coherent Radiation Laboratories | 1983-03-04 | 28 | 0 |
| K827383 | MODEL 900 PHOTOCOAGULATOR WITH GREEN-ONLY OPTIONS | Coherent Radiation Laboratories | 1982-11-23 | 25 | 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