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

Lightmed Corp. — Predicate Candidate Screening

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

196 daysmedian FDA review time

336 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K142172	LIGHTMED TRUSCAN 577	Lightmed Corp.	2015-02-27	204	0
K124043	LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM	Lightmed Corp.	2013-09-26	272	0
K103547	LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM	Lightmed Corp.	2011-11-03	336	0
K091981	LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER	Lightmed Corp.	2009-09-28	89	0
K091534	LIGHTLAS MODEL 532	Lightmed Corp.	2009-09-18	115	0
K090774	LIGHTLAS SELECTOR	Lightmed Corp.	2009-08-13	143	0
K063297	LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR	Lightmed Corp.	2007-09-20	323	0
K021538	LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR	Lightmed Corp.	2002-08-08	90	0
K010372	LIGHTLAS 532 PHOTOCOAGULATOR	Lightmed Corp.	2001-08-22	196	1

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