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

Electrode, Corneal

21 CFR 886.1220 / Ophthalmic
FDA source (opens on fda.gov)

HLZ is the FDA product code for Electrode, Corneal, a class II device type, regulated under 21 CFR 886.1220. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HLZ
Device name
Electrode, Corneal
Regulation
21 CFR 886.1220
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
0

Clearances, product code HLZ

By decision year
11 clearances under product code HLZ with a decision year between 1976 and 2026, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HLZ by decision year
YearClearances
19761
19781
19822
19831
19851
19921
19941
19971
20231
20261

Applicants with the most clearances

Product code HLZ
Applicants holding the most 510(k) clearances under product code HLZ
ApplicantClearances
Retmap, Inc.2
Cadwell Laboratories, Inc.1
Doran Instruments, Inc.1
Life-Tech Instruments, Inc.1
LKC Technologies, Inc.1
Nicolet Biomedical Instruments1
Sauquoit Industries, Inc.1
Thomasville Medical Assoc.1
Tomey Corporation USA1
Universo S.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code