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

Frame, Trial, Ophthalmic

21 CFR 886.1415 / Ophthalmic
FDA source (opens on fda.gov)

HPA is the FDA product code for Frame, Trial, Ophthalmic, a class I device type, regulated under 21 CFR 886.1415. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HPA
Device name
Frame, Trial, Ophthalmic
Regulation
21 CFR 886.1415
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code HPA

By decision year
5 clearances under product code HPA with a decision year between 1982 and 1985, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HPA by decision year
YearClearances
19821
19842
19852

Applicants with the most clearances

Product code HPA
Applicants holding the most 510(k) clearances under product code HPA
ApplicantClearances
Ascon Medical Instruments, Ltd.2
Medical Equipment Designs, Inc.1
Michael Onufryk1
Woodlyn, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 59 companies shown, in name order