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

Unit, Cryophthalmic, Ac-Powered

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

HRN is the FDA product code for Unit, Cryophthalmic, Ac-Powered, a class II device type, regulated under 21 CFR 886.4170. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HRN
Device name
Unit, Cryophthalmic, Ac-Powered
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
10
Ingested recalls
0

Clearances, product code HRN

By decision year
10 clearances under product code HRN with a decision year between 1983 and 2020, 2017 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HRN by decision year
YearClearances
19831
19991
20011
20061
20111
20131
20172
20181
20201

Applicants with the most clearances

Product code HRN
Applicants holding the most 510(k) clearances under product code HRN
ApplicantClearances
Keeler Instruments, Inc.3
Phakos3
Dutch Ophthalmic Research Center International BV1
Dutch Ophthalmic USA, Inc.1
Keeler Ltd.1
Terumo Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code