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

Telescope, Spectacle, Low-Vision

21 CFR 886.5870 / Ophthalmic
FDA source (opens on fda.gov)

HKK is the FDA product code for Telescope, Spectacle, Low-Vision, a class I device type, regulated under 21 CFR 886.5870. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HKK
Device name
Telescope, Spectacle, Low-Vision
Regulation
21 CFR 886.5870
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code HKK

By decision year
2 clearances under product code HKK with a decision year between 1987 and 1987, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HKK by decision year
YearClearances
19872

Applicants with the most clearances

Product code HKK
Applicants holding the most 510(k) clearances under product code HKK
ApplicantClearances
Global Eye Care, Inc.1
Keeler Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code