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

Optimedica Corporation — Predicate Candidate Screening

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

117 daysmedian FDA review time

140 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K161455	Catalys Precision Laser System	Optimedica Corporation	2016-09-20	117	0
K141079	OPTIMEDICA CATALYS PRECISION LASER SYSTEM	Optimedica Corporation	2014-09-11	139	2
K121091	CATALYS PRECISION LASER SYSTEM	Optimedica Corporation	2012-08-28	140	1
K113479	OPTIMEDICA CATALYS PRECISION LASER SYSTEM	Optimedica Corporation	2011-12-21	28	0
K100019	PASCAL STREAMLINE PHOTOCOAGULATOR	Optimedica Corporation	2010-05-04	119	1
K091666	PASCAL PHOTOCOAGULATOR, PASCAL-US	Optimedica Corporation	2009-07-15	36	0
K081744	PASCAL SYNTHESIS DELIVERY SYSTEM	Optimedica Corporation	2008-09-09	82	0
K062336	OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE	Optimedica Corporation	2006-10-19	70	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