Product Code: HOY FDA class 1 21 CFR 886.4750

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

Ophthalmic

An Ophthalmic Eye Shield (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) is a protective device worn over one or both eyes to shield them from light, trauma, or contamination following ophthalmic procedures, pharmacological dilation, or exposure to ultraviolet radiation sources such as sunlamps. This device is FDA Class 1 (lowest risk), subject only to general controls without requiring premarket notification. It carries product code HOY and is regulated under 21 CFR 886.4750, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.

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510(k)s

FEI Numbers

712

Registration Numbers

712

Unique Applicants

Years Active

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Basic Information

Product Code: HOY
Device Class: FDA class 1
Regulation Number: 886.4750
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 55 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K132042	AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND	Apr 28, 2014	Substantially Equivalent	X6d, Ltd.
K050856	LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM	May 31, 2005	Substantially Equivalent	Ophthocare , Ltd.
K971465	NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS	Jun 04, 1997	Substantially Equivalent	National Healthcare Mfg. Corp.
K944700	ARCTIC PREMIER SERIES	Dec 22, 1994	Substantially Equivalent	Sungold Eyewear, Inc.
K944857	GOGGLE SAFEGUARD	Dec 15, 1994	Substantially Equivalent	Sellstrom Mfg. Co.
K945351	SHIELD, EYE, OPHTHALMIC	Dec 13, 1994	Substantially Equivalent	Taiwan Eva Industrial Co., Inc.
K945346	MAKROLON 2405 GOGGLES (LIGHT AND DARK)	Nov 22, 1994	Substantially Equivalent	Universal Massage & Tanning, Inc.
K942407	AMCON SLIP IN MYDRIATIC SUNGLASSES	Jun 06, 1994	Substantially Equivalent	Amcon Laboratories, Inc.
K941829	SUN FILTERS/SHIELDS	May 17, 1994	Substantially Equivalent	Klinger Eye Shields, Inc.
K930347	SHAIDS PROTECTIVE GLASSES	Apr 29, 1994	Substantially Equivalent	Depuy, Inc.
K940275	UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD	Mar 24, 1994	Substantially Equivalent	P.J. Products, Inc.
K940213	UNIVERSAL CUSHIONED METAL EYE SHIELD	Mar 24, 1994	Substantially Equivalent	P.J. Products, Inc.
K940095	FOX EYE ALUMINUM SHIELD, OPHTHALMIC	Mar 01, 1994	Substantially Equivalent	P.J. Products, Inc.
K930840	POST-MYDS(TM)	Mar 01, 1994	Substantially Equivalent	Aukland Medical Plastics, Inc.
K934085	MODIFICATION OF SURGICAL EYESHIELD MASK	Nov 12, 1993	Substantially Equivalent	American Threshold Industries, Inc.
K931254	GOGGLE SAFEGUARD	Nov 12, 1993	Substantially Equivalent	Sellstrom Mfg. Co.
K925564	ACTION MEDTEK/DENTEK EYEGLASSES	Oct 07, 1993	Substantially Equivalent	Action Eyewear Corp.
K912576	INSTRUMENT WIPE AND CORNEAL SHIELD	Jan 31, 1992	Substantially Equivalent	Katena Products, Inc.
K914095	PEEPERS TANNING GOGGLES	Oct 30, 1991	Substantially Equivalent	California Suncare, Inc.
K913230	UNIDIRECTIONAL OCCLUDER	Oct 02, 1991	Substantially Equivalent	Welch Allyn, Inc.
K912367	EYE BUBBLE	Oct 02, 1991	Substantially Equivalent	Aaron Medical Industries
K900942	OCULAR OCCLUDER	May 25, 1990	Substantially Equivalent	Microdynamics
K900941	OMNIPATCH	May 21, 1990	Substantially Equivalent	Eye Garter Company, Inc.
K896681	SOFT CORNEAL LIGHT SHIELD	Jan 11, 1990	Substantially Equivalent	Visitec Co.
K896172	STRAPPED EYE SHIELD	Nov 03, 1989	Substantially Equivalent	Eye Garter Company, Inc.
K896171	EYE PATCH	Nov 03, 1989	Substantially Equivalent	Eye Garter Company, Inc.
K895364	LID LOC	Oct 31, 1989	Substantially Equivalent	Spectrum Co.
K894724	SAFE-EDGE EYESHIELD	Sep 14, 1989	Substantially Equivalent	Trident Medical Products, Inc.
K894720	UNIVERSAL EYESHIELD	Sep 14, 1989	Substantially Equivalent	Trident Medical Products, Inc.
K885163	DIOPTICS EYESHIELDS	Dec 30, 1988	Substantially Equivalent	Dioptics
K880489	CLEAR EYE GARTER SHIELD	Aug 08, 1988	Substantially Equivalent	Eye Garter Company, Inc.
K881135	COOL EYE(TM) EYE PROTECTOR	Jul 08, 1988	Substantially Equivalent	Cool Eyes, Inc.
K880666	ULTRAVIOLET LIGHT PROTECTVE EYEWERE	Jun 28, 1988	Substantially Equivalent	Free Sun Intl. AB
K880490	BLUE PLASTIC EYE SHIELD	May 03, 1988	Substantially Equivalent	Eye Garter Company, Inc.
K881232	SURGIN EYE SHIELD	Apr 13, 1988	Substantially Equivalent	Surgeon Surgical Instrumentation, Inc.
K880675	EASY SHIELD ADHESIVE BANDAGE	Apr 01, 1988	Substantially Equivalent	Eye Garter Company, Inc.
K875302	MEDICAL EYE DISPOSABLE SHIELD	Mar 21, 1988	Substantially Equivalent	Bfd, Inc.
K875107	HEALTH CARE EYE PROTECTION	Mar 21, 1988	Substantially Equivalent	Surgikos, Inc.
K873662	WINK-EASE PERSONAL PROTECTIVE EYEWEAR	Oct 02, 1987	Substantially Equivalent	Eye Pro Medical Products, Inc.
K872659	TAPELESS EYE SHIELD	Jul 27, 1987	Substantially Equivalent	Precision Therapeutics, Inc.
K872000	EYE GARD	Jul 21, 1987	Substantially Equivalent	Treace Medical, Inc.
K863474	KASEY EYE SHIELD	Sep 24, 1986	Substantially Equivalent	Kasey Enterprises, Inc.
K853035	HESSBURG LIGHT GUARD	Dec 13, 1985	Substantially Equivalent	Visitec Co.
K852404	LASERSAFE EYE SHIELDS	Oct 04, 1985	Substantially Equivalent	Lasersafe, Inc.
K844761	SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD	Dec 24, 1984	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K843961	COLOR OPTIC CORNEAL EYE SHIELD	Nov 28, 1984	Substantially Equivalent	Colors IN Optics , Ltd.
K840834	CORNEAL LIGHT SHIELD	Oct 05, 1984	Substantially Equivalent	Gabl, Inc.
K840414	COLOR OPTIC CORNEAL EYE SHIELD	Aug 15, 1984	Substantially Equivalent	Diversations, Inc.
K841599	STORZ UNIVERSAL EYE SHIELD	May 22, 1984	Substantially Equivalent	Storz Instrument Co.
K840444	NEONATE MASK FOR BABIES	Mar 16, 1984	Substantially Equivalent	Richards Medical Co., Inc.
K833256	CROUCH CORNEAL PROTECTOR	Feb 08, 1984	Substantially Equivalent	Star Instrument Co.
K821765	PHOTOTHERAPY EYE PROTECTION FOR INFANTS	Aug 16, 1982	Substantially Equivalent	Russell Terry Co.
K811577	CROUCH CORNEAL PROTECTOR	Aug 07, 1981	Substantially Equivalent	Denver Biomedicals, Inc.
K810098	FOX EYE SHIELDS	Feb 27, 1981	Substantially Equivalent	American Hospital Supply Corp.
K802786	POROPLAST-EYE DRESSING	Dec 17, 1980	Substantially Equivalent	Secol Co.