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

Intra Lase Corp. — Predicate Candidate Screening

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

143 daysmedian FDA review time

381 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K073404	IFS LASER SYSTEM	Intra Lase Corp.	2008-04-25	143	0
K063682	INTRALASE FUSION LASER	Intra Lase Corp.	2007-02-09	60	0
K060372	INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3	Intra Lase Corp.	2006-08-16	184	0
K041893	INTRALASE FS LASER	Intra Lase Corp.	2005-07-29	381	0
K031960	INTRALASE FS LASER	Intra Lase Corp.	2003-09-29	96	3
K013941	PULSION FS LASER KERATOME	Intra Lase Corp.	2002-02-27	90	1
K002890	INTRALASE 600C LASER KERATOME	Intra Lase Corp.	2001-08-09	328	1
K001211	MODIFICATION TO INTRALASE 600C LASER KERATOME	Intra Lase Corp.	2000-12-04	234	1
K993153	INTRALASE 600C LASER KERATOME	Intra Lase Corp.	1999-12-17	87	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