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

Monitor, Eye Movement

21 CFR 886.1510 / Ophthalmic
FDA source (opens on fda.gov)

HLL is the FDA product code for Monitor, Eye Movement, a class II device type, regulated under 21 CFR 886.1510. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HLL
Device name
Monitor, Eye Movement
Regulation
21 CFR 886.1510
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
4
Ingested recalls
0

Clearances, product code HLL

By decision year
4 clearances under product code HLL with a decision year between 1988 and 2023, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HLL by decision year
YearClearances
19881
20041
20161
20231

Applicants with the most clearances

Product code HLL
Applicants holding the most 510(k) clearances under product code HLL
ApplicantClearances
C. Light Technologies, Inc.1
Essilor Intl.1
Ober Consulting Sp. Z.O.O.1
Orthotone Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code