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

Keratoscope, Battery-Powered

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

HLR is the FDA product code for Keratoscope, Battery-Powered, a class I device type, regulated under 21 CFR 886.1350. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HLR
Device name
Keratoscope, Battery-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
Yes
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code HLR

By decision year
7 clearances under product code HLR with a decision year between 1982 and 1990, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HLR by decision year
YearClearances
19821
19831
19851
19861
19882
19901

Applicants with the most clearances

Product code HLR
Applicants holding the most 510(k) clearances under product code HLR
ApplicantClearances
Cutler Medical Instruments1
Gamut Ent.1
JEDMED Instrument Company1
Medical Equipment Designs, Inc.1
Surgidev Corp.1
Technitex, Inc.1
The Sanborn Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code