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

Reader, Prism, Ophthalmic

21 CFR 886.5810 / Ophthalmic
FDA source (opens on fda.gov)

HJX is the FDA product code for Reader, Prism, Ophthalmic, a class I device type, regulated under 21 CFR 886.5810. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HJX
Device name
Reader, Prism, Ophthalmic
Regulation
21 CFR 886.5810
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 HJX

By decision year
1 clearance under product code HJX with a decision year between 2000 and 2000, 2000 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HJX by decision year
YearClearances
20001

Applicants with the most clearances

Product code HJX
Applicants holding the most 510(k) clearances under product code HJX
ApplicantClearances
Labtician Ophthalmics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code