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

Gauge, Lens, Ophthalmic

21 CFR 886.1420 / Ophthalmic
FDA source (opens on fda.gov)

HLN is the FDA product code for Gauge, Lens, Ophthalmic, a class I device type, regulated under 21 CFR 886.1420. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HLN
Device name
Gauge, Lens, Ophthalmic
Regulation
21 CFR 886.1420
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
2
Ingested recalls
0

Clearances, product code HLN

By decision year
2 clearances under product code HLN with a decision year between 1980 and 1985, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HLN by decision year
YearClearances
19801
19851

Applicants with the most clearances

Product code HLN
Applicants holding the most 510(k) clearances under product code HLN
ApplicantClearances
Ascon Medical Instruments, Ltd.1
Edward Weck, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 40 companies shown, in name order