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

Perimeter, Automatic, Ac-Powered

21 CFR 886.1605 / Ophthalmic
FDA source (opens on fda.gov)

HPT is the FDA product code for Perimeter, Automatic, Ac-Powered, a class I device type, regulated under 21 CFR 886.1605. As of , FDA records hold 41 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HPT
Device name
Perimeter, Automatic, Ac-Powered
Regulation
21 CFR 886.1605
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
41
Ingested recalls
1

Clearances, product code HPT

By decision year
41 clearances under product code HPT with a decision year between 1978 and 2010, 1982 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HPT by decision year
YearClearances
19782
19791
19801
19813
19824
19832
19843
19854
19872
19883
19891
19901
19932
19942
19952
19961
19971
20031
20051
20071
20091
20102

Applicants with the most clearances

Product code HPT
Applicants holding the most 510(k) clearances under product code HPT
ApplicantClearances
Bio-Rad3
Dicon, Inc.3
Synemed, Inc.3
Cavitron Corp.2
Kowa Pharmaceuticals America, Inc.2
Notal Vision Ltd.2
Optimed, Inc.2
Vismed, Inc.2
Zeiss Humphrey System2
Carl Zeiss Meditec Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 65 companies shown, in name order