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

Photocoagulator And Accessories

21 CFR 886.4690 / Ophthalmic
FDA source (opens on fda.gov)

HQB is the FDA product code for Photocoagulator And Accessories, a class II device type, regulated under 21 CFR 886.4690. As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and 32 recalls.

Classification record

Product code
HQB
Device name
Photocoagulator And Accessories
Regulation
21 CFR 886.4690
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
30
Ingested recalls
32

Clearances, product code HQB

By decision year
30 clearances under product code HQB with a decision year between 1976 and 2022, 1984 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HQB by decision year
YearClearances
19761
19771
19781
19801
19843
19852
19861
19883
19921
19932
19953
19971
20113
20121
20133
20192
20221

Applicants with the most clearances

Product code HQB
Applicants holding the most 510(k) clearances under product code HQB
ApplicantClearances
Gamp & Assoc.3
Nidek, Inc.3
Peregrine Surgical, LLC.3
Cavitron Corp.2
Surgical Laser Technologies, Inc.2
Varian Assoc., Inc.2
Vortex Surgical, Inc.2
Advanced Surgical Products, Inc.1
Alcon Laboratories1
American Medical Optics1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order