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

Lamp, Fluorescein, Ac-Powered

21 CFR 878.4580 / General, Plastic Surgery
FDA source (opens on fda.gov)

HJE is the FDA product code for Lamp, Fluorescein, Ac-Powered, a class II device type, regulated under 21 CFR 878.4580. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HJE
Device name
Lamp, Fluorescein, Ac-Powered
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code HJE

By decision year
3 clearances under product code HJE with a decision year between 1978 and 1992, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HJE by decision year
YearClearances
19781
19801
19921

Applicants with the most clearances

Product code HJE
Applicants holding the most 510(k) clearances under product code HJE
ApplicantClearances
American Cyanamid Co.1
American Sterilizer Co.1
Strato-Ray Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code HJE.