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

Shell, Scleral

21 CFR 886.3800 / Ophthalmic
FDA source (opens on fda.gov)

HQT is the FDA product code for Shell, Scleral, a class II device type, regulated under 21 CFR 886.3800. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HQT
Device name
Shell, Scleral
Regulation
21 CFR 886.3800
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code HQT

By decision year
4 clearances under product code HQT with a decision year between 1986 and 1997, 1997 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HQT by decision year
YearClearances
19861
19911
19972

Applicants with the most clearances

Product code HQT
Applicants holding the most 510(k) clearances under product code HQT
ApplicantClearances
Midwest Eye Laboratories, Inc.1
Mira, Inc.1
Southwest Artificial Eyes, Inc.1
Xavier A. Guerra, Ocularist, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code