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

Magnifier, Hand-Held, Low-Vision

21 CFR 886.5540 / Ophthalmic
FDA source (opens on fda.gov)

HJF is the FDA product code for Magnifier, Hand-Held, Low-Vision, a class I device type, regulated under 21 CFR 886.5540. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HJF
Device name
Magnifier, Hand-Held, Low-Vision
Regulation
21 CFR 886.5540
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
1
Ingested recalls
0

Clearances, product code HJF

By decision year
1 clearance under product code HJF with a decision year between 1982 and 1982, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HJF by decision year
YearClearances
19821

Applicants with the most clearances

Product code HJF
Applicants holding the most 510(k) clearances under product code HJF
ApplicantClearances
Gazelle Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 53 companies shown, in name order