HOY · Class I · 21 CFR 886.4750

FDA Product Code HOY: Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)

Leading manufacturers include Visitec Co., Treace Medical, Inc. and Surgikos, Inc..

55
Total
55
Cleared
98d
Avg days
1980
Since

FDA 510(k) Cleared Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) Devices (Product Code HOY)

55 devices
1–24 of 55
Cleared Apr 28, 2014
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
K132042
X6d, Ltd.
Ophthalmic · 300d
Cleared May 31, 2005
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
K050856
Ophthocare , Ltd.
Ophthalmic · 56d
Cleared Jun 04, 1997
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
K971465
National Healthcare Mfg. Corp.
General Hospital · 43d
Cleared Apr 29, 1994
SHAIDS PROTECTIVE GLASSES
K930347
Depuy, Inc.
Ophthalmic · 459d
Cleared Nov 12, 1993
MODIFICATION OF SURGICAL EYESHIELD MASK
K934085
American Threshold Industries, Inc.
Ophthalmic · 84d
Cleared Oct 02, 1991
EYE BUBBLE
K912367
Aaron Medical Industries
Ophthalmic · 126d
Cleared Oct 02, 1991
UNIDIRECTIONAL OCCLUDER
K913230
Welch Allyn, Inc.
Ophthalmic · 72d
Cleared Jan 11, 1990
SOFT CORNEAL LIGHT SHIELD
K896681
Visitec Co.
Ophthalmic · 45d
Cleared Mar 21, 1988
HEALTH CARE EYE PROTECTION
K875107
Surgikos, Inc.
Ophthalmic · 98d
Cleared Jul 21, 1987
EYE GARD
K872000
Treace Medical, Inc.
Ophthalmic · 56d
Cleared Dec 13, 1985
HESSBURG LIGHT GUARD
K853035
Visitec Co.
Ophthalmic · 148d
Cleared Dec 24, 1984
SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD
K844761
Medical Instrument Development Laboratories, Inc.
Ophthalmic · 17d
Cleared May 22, 1984
STORZ UNIVERSAL EYE SHIELD
K841599
Storz Instrument Co.
Ophthalmic · 34d
Cleared Mar 16, 1984
NEONATE MASK FOR BABIES
K840444
Richards Medical Co., Inc.
Ophthalmic · 44d
Cleared Feb 27, 1981
FOX EYE SHIELDS
K810098
American Hospital Supply Corp.
Ophthalmic · 39d
Cleared Dec 17, 1980
POROPLAST-EYE DRESSING
K802786
Secol Co.
Ophthalmic · 43d

About Product Code HOY - Regulatory Context