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

Set, Lens, Trial, Ophthalmic

21 CFR 886.1405 / Ophthalmic
FDA source (opens on fda.gov)

HPC is the FDA product code for Set, Lens, Trial, Ophthalmic, a class I device type, regulated under 21 CFR 886.1405. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HPC
Device name
Set, Lens, Trial, Ophthalmic
Regulation
21 CFR 886.1405
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
13
Ingested recalls
0

Clearances, product code HPC

By decision year
13 clearances under product code HPC with a decision year between 1977 and 1995, 1993 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HPC by decision year
YearClearances
19771
19842
19851
19871
19901
19921
19933
19941
19952

Applicants with the most clearances

Product code HPC
Applicants holding the most 510(k) clearances under product code HPC
ApplicantClearances
R.H. Burton Co.2
Woodlyn, Inc.2
Arno Intl., Inc.1
Ascon Medical Instruments, Ltd.1
Bobes S.A.1
Cerenovus, Inc.1
Marco Ophthalmic, Inc.1
Optek Medico Co., Ltd.1
Optimark Accessories and Instruments1
Oti Medical, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 55 companies shown, in name order