510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LQJClass II

Lens, Surgical, Laser, Accesssory, Ophthalmic Laser

21 CFR 886.4390 / Ophthalmic
FDA source (opens on fda.gov)

LQJ is the FDA product code for Lens, Surgical, Laser, Accesssory, Ophthalmic Laser, a class II device type, regulated under 21 CFR 886.4390. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LQJ
Device name
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
13
Ingested recalls
1

Clearances, product code LQJ

By decision year
13 clearances under product code LQJ with a decision year between 1986 and 2017, 1988 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LQJ by decision year
YearClearances
19861
19873
19884
19891
19911
19921
19931
20171

Applicants with the most clearances

Product code LQJ
Applicants holding the most 510(k) clearances under product code LQJ
ApplicantClearances
Ocular Instruments, Inc.6
California Laboratories, Inc.2
Biophysic Medical, Inc.1
Chiron Vision Corp.1
Katalyst Surgical, LLC1
Sorenson Laboratories, Inc.1
Tomey Corporation USA1

Companies listing this code with FDA

Companies whose registered establishments list this code