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

LQJ — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

48 daysmedian FDA review time

175 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K163632	Katalyst Cyclophotocoagulation Probe	Katalyst Surgical, LLC	2017-06-15	175
K931356	SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR	Sorenson Laboratories, Inc.	1993-09-07	174
K921414	TROKEL /3 GONIO LASER LENS	Ocular Instruments, Inc.	1992-11-16	237
K912112	PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480	Tomey Corporation USA	1991-06-17	35
K893731	SHIELDS T.C. LASER LENS	Ocular Instruments, Inc.	1989-08-17	92
K884694	MQL 20 ND:YAG OPHTHALMIC LASER	California Laboratories, Inc.	1988-11-30	21
K883719	INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM	Biophysic Medical, Inc.	1988-10-18	48
K883270	IRIS ND:YAG OPTHALMIC LASER	California Laboratories, Inc.	1988-10-13	71
K882574	BOLDREY PERIPHERAL RETINAL LENS	Ocular Instruments, Inc.	1988-07-29	37
K872802	TROKEL SINGLE MIRROR YAG LASER LENS	Ocular Instruments, Inc.	1987-09-04	51
K871245	LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1	Chiron Vision Corp.	1987-05-07	41
K871099	SCHIRMER NYLON SUTURE LASER LENS	Ocular Instruments, Inc.	1987-04-27	39
K862869	PETRUS SINGLE MIRROR LASER LENS	Ocular Instruments, Inc.	1986-08-21	23

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