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

Transilluminator, Battery-Powered

21 CFR 886.1945 / Ophthalmic
FDA source (opens on fda.gov)

HJN is the FDA product code for Transilluminator, Battery-Powered, a class I device type, regulated under 21 CFR 886.1945. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HJN
Device name
Transilluminator, Battery-Powered
Regulation
21 CFR 886.1945
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
3
Ingested recalls
1

Clearances, product code HJN

By decision year
3 clearances under product code HJN with a decision year between 1990 and 1994, 1990 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HJN by decision year
YearClearances
19901
19911
19941

Applicants with the most clearances

Product code HJN
Applicants holding the most 510(k) clearances under product code HJN
ApplicantClearances
Lumitex Medical Devices, Inc.1
Sylvan Corp.1
Trinity Partners, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order