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

Preamplifier, Ac-Powered, Ophthalmic

21 CFR 886.1640 / Ophthalmic
FDA source (opens on fda.gov)

HLT is the FDA product code for Preamplifier, Ac-Powered, Ophthalmic, a class II device type, regulated under 21 CFR 886.1640. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HLT
Device name
Preamplifier, Ac-Powered, Ophthalmic
Regulation
21 CFR 886.1640
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 HLT

By decision year
4 clearances under product code HLT with a decision year between 1978 and 1994, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HLT by decision year
YearClearances
19781
19841
19921
19941

Applicants with the most clearances

Product code HLT
Applicants holding the most 510(k) clearances under product code HLT
ApplicantClearances
Chalgren Enterprises, Inc.1
Keller Instruments, Inc.1
Sonometrics Systems, Inc.1
Tomey Corporation USA1

Companies listing this code with FDA

Companies whose registered establishments list this code