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

Eye, Artificial, Non-Custom

21 CFR 886.3200 / Ophthalmic
FDA source (opens on fda.gov)

HQH is the FDA product code for Eye, Artificial, Non-Custom, a class I device type, regulated under 21 CFR 886.3200. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HQH
Device name
Eye, Artificial, Non-Custom
Regulation
21 CFR 886.3200
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code HQH

By decision year
6 clearances under product code HQH with a decision year between 1980 and 1995, 1995 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HQH by decision year
YearClearances
19801
19911
19921
19953

Applicants with the most clearances

Product code HQH
Applicants holding the most 510(k) clearances under product code HQH
ApplicantClearances
Daniel T Acosta1
Frank Tanaka, Ocularist, Inc.1
Midwest Eye Laboratories, Inc.1
Nissel, Ltd.1
Ocularists, Ltd.1
Robert B. Scott Ocularists of Florida, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order