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

Photokeratoscope

21 CFR 886.1350 / Ophthalmic
FDA source (opens on fda.gov)

HJA is the FDA product code for Photokeratoscope, a class I device type, regulated under 21 CFR 886.1350. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HJA
Device name
Photokeratoscope
Regulation
21 CFR 886.1350
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code HJA

By decision year
5 clearances under product code HJA with a decision year between 1978 and 1990, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HJA by decision year
YearClearances
19781
19831
19841
19891
19901

Applicants with the most clearances

Product code HJA
Applicants holding the most 510(k) clearances under product code HJA
ApplicantClearances
American Medical Optics1
Clifford M. Terry, M.C.1
JEDMED Instrument Company1
Technitex, Inc.1
The Sanborn Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code