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

Keratoscope, Ac-Powered

21 CFR 886.1350 / Ophthalmic
FDA source (opens on fda.gov)

HLQ is the FDA product code for Keratoscope, Ac-Powered, a class I device type, regulated under 21 CFR 886.1350. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HLQ
Device name
Keratoscope, Ac-Powered
Regulation
21 CFR 886.1350
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
29
Ingested recalls
0

Clearances, product code HLQ

By decision year
29 clearances under product code HLQ with a decision year between 1979 and 2001, 1990 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HLQ by decision year
YearClearances
19791
19831
19841
19853
19862
19872
19892
19904
19913
19921
19932
19943
19951
19972
20011

Applicants with the most clearances

Product code HLQ
Applicants holding the most 510(k) clearances under product code HLQ
ApplicantClearances
Computed Anatomy, Inc.3
Canon Medical Components U.S.A., Inc.2
Kera Corp.2
Nidek, Inc.2
Alcon Laboratories1
Alliance Medical Marketinig1
Carl Zeiss, Inc.1
Cci1
Expertech Assoc., Inc.1
Eyesys Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order