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

Unit, Cryophthalmic

21 CFR 886.4170 / Ophthalmic
FDA source (opens on fda.gov)

HPS is the FDA product code for Unit, Cryophthalmic, a class II device type, regulated under 21 CFR 886.4170. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
HPS
Device name
Unit, Cryophthalmic
Regulation
21 CFR 886.4170
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
11
Ingested recalls
4

Clearances, product code HPS

By decision year
11 clearances under product code HPS with a decision year between 1979 and 2020, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HPS by decision year
YearClearances
19792
19801
19841
19872
19881
19901
19921
19941
20201

Applicants with the most clearances

Product code HPS
Applicants holding the most 510(k) clearances under product code HPS
ApplicantClearances
Keeler Instruments, Inc.2
Dutch Ophthalmic USA, Inc.1
Edward Weck, Inc.1
Intermedics, Inc.1
Keeler Optical Products, Ltd.1
Mira, Inc.1
Mono Research Laboratories1
Spembly Medical, Ltd.1
United Surgical LLC1
Vitreq BV1

Companies listing this code with FDA

Companies whose registered establishments list this code