510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
HQAClass II

Unit, Cryotherapy, Ophthalmic

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

HQA is the FDA product code for Unit, Cryotherapy, Ophthalmic, a class II device type, regulated under 21 CFR 886.4170. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HQA
Device name
Unit, Cryotherapy, Ophthalmic
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
4
Ingested recalls
0

Clearances, product code HQA

By decision year
4 clearances under product code HQA with a decision year between 1983 and 1985, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HQA by decision year
YearClearances
19831
19841
19852

Applicants with the most clearances

Product code HQA
Applicants holding the most 510(k) clearances under product code HQA
ApplicantClearances
Keeler Instruments, Inc.2
Keller Instruments, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code