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

Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

21 CFR 886.4750 / Ophthalmic
FDA source (opens on fda.gov)

HOY is the FDA product code for Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear), a class I device type, regulated under 21 CFR 886.4750. As of , FDA records hold 55 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HOY
Device name
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Regulation
21 CFR 886.4750
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
55
Ingested recalls
1

Clearances, product code HOY

By decision year
55 clearances under product code HOY with a decision year between 1980 and 2014, 1994 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code HOY by decision year
YearClearances
19801
19812
19821
19847
19852
19861
19873
19889
19895
19903
19913
19921
19933
199411
19971
20051
20141

Applicants with the most clearances

Product code HOY
Applicants holding the most 510(k) clearances under product code HOY
ApplicantClearances
Eye Garter Company, Inc.6
P.J. Products, Inc.3
Sellstrom Mfg. Co.2
Trident Medical Products, Inc.2
Visitec Co.2
Apyx Medical Corporation1
Action Eyewear Corp.1
Amcon Laboratories, Inc.1
American Hospital Supply1
American Threshold Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 699 companies shown, in name order