Atlas FDA

HLZ

11 FDA 510(k) clearances · Product code

92 daysmedian time to decision
364 days90th percentile
11clearances measured

FDA profile

Official device name
Electrode, Corneal
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1220
Medical specialty
Ophthalmic
Flags
Third-party review eligible
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RecordFirmDate
RM Electrode (RMH 25-01) (K253586)Retmap, Inc.2026-04-01
RM Electrode (RMH 23-01) (K232273)Retmap, Inc.2023-12-07
TOMEY DTL ELECTRODE (K961805)Tomey Corporation USA1997-05-09
SOPHER AND BIERER OVUM FORCEPS (K926540)Thomasville Medical Assoc.1994-02-25
GOLDLENS(TM) (K913239)Doran Instruments, Inc.1992-01-31
DTL ELECTRODE (K844409)Sauquoit Industries, Inc.1985-02-14
ERG-JET ELECTRODE (K830557)Universo S.A.1983-03-31
GOLD FOIL ERG ELECTRODES (K820254)Cadwell Laboratories, Inc.1982-04-09
ERG-JET ELECTRODE (K813399)Nicolet Biomedical Instruments1982-01-22
MULAR GOLD LEAF ELECTRODE MODEL 7501 (K781476)Life-Tech Instruments, Inc.1978-11-15
ELECTRORETINOGRAPH (K760199)Lkc Technologies, Inc.1976-08-04

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Every clearance here is in the API, with alerts when new ones post.