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

Device, Measuring, Lens Radius, Ophthalmic

21 CFR 886.1430 / Ophthalmic
FDA source (opens on fda.gov)

HLF is the FDA product code for Device, Measuring, Lens Radius, Ophthalmic, a class I device type, regulated under 21 CFR 886.1430. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HLF
Device name
Device, Measuring, Lens Radius, Ophthalmic
Regulation
21 CFR 886.1430
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
3
Ingested recalls
1

Clearances, product code HLF

By decision year
3 clearances under product code HLF with a decision year between 1983 and 1993, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HLF by decision year
YearClearances
19831
19861
19931

Applicants with the most clearances

Product code HLF
Applicants holding the most 510(k) clearances under product code HLF
ApplicantClearances
Bausch & Lomb Incorporated1
Life-Tech Intl., Inc.1
Marco Ophthalmic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order