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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Coherent Medical Division · Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

85 daysmedian FDA review time
97 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K902990COHERENT HOLMIUM:YAG SURGICAL LASERCoherent Medical Division1990-10-02850
K822908COHERENT FUNDUSL RETINAL CAMERACoherent Medical Division1983-01-05970
K822415THE OCUPLOT DCoherent Medical Division1982-09-07270
K801906DIOPTRON III AUTOREFRACTORCoherent Medical Division1980-08-27160
K801336MODEL 900K PHOTOCOAGULATORCoherent Medical Division1980-07-28540
K791895ACCESSORIES FOR SYS. 400 CO2 SURG. LASERCoherent Medical Division1979-12-20860

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