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

Photostimulator, Ac-Powered

21 CFR 886.1630 / Ophthalmic
FDA source (opens on fda.gov)

HLX is the FDA product code for Photostimulator, Ac-Powered, a class II device type, regulated under 21 CFR 886.1630. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HLX
Device name
Photostimulator, Ac-Powered
Regulation
21 CFR 886.1630
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
18
Ingested recalls
0

Clearances, product code HLX

By decision year
18 clearances under product code HLX with a decision year between 1979 and 2001, 1982 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HLX by decision year
YearClearances
19791
19812
19824
19833
19841
19851
19881
19911
19921
19931
19991
20011

Applicants with the most clearances

Product code HLX
Applicants holding the most 510(k) clearances under product code HLX
ApplicantClearances
Life-Tech Intl., Inc.4
Cadwell Laboratories, Inc.2
Electro-Diagnostic Imaging, Inc.2
Biosan Laboratories, Inc.1
Clarus Medical Systems, Inc.1
LKC Technologies, Inc.1
Nicolet Biomedical Instruments1
Potomac Medical System1
Randwal Instrument Co., Inc.1
Retina Tester1

Companies listing this code with FDA

Companies whose registered establishments list this code

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