Product Code: HQH FDA class 1 21 CFR 886.3200

Eye, Artificial, Non-Custom

Ophthalmic

A Non-Custom Artificial Eye is a prefabricated ocular prosthesis manufactured to standard shapes and sizes, worn within the eye socket following enucleation or evisceration to restore the natural cosmetic appearance of the eye. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification or approval. It carries product code HQH and is regulated under 21 CFR 886.3200, within the Ophthalmic medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HQH
Device Class: FDA class 1
Regulation Number: 886.3200
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K952538	ROBERT B. SCOTT PLASTIC ARTIFICAL	Jun 26, 1995	Substantially Equivalent	Robert B. Scott Ocularists of Florida, Inc.
K945270	CUSTOM ARTIFICIAL HUMAN EYES	May 30, 1995	Substantially Equivalent	Daniel T Acosta
K946226	CUSTOM OCULAR PROSTHESIS	Mar 22, 1995	Substantially Equivalent	Frank Tanaka, Ocularist, Inc.
K923167	THE NISSEL ARTIFICIAL EYE	Sep 02, 1992	Substantially Equivalent	Nissel , Ltd.
K904962	EYE ARTIFICIAL CUSTOM	Aug 30, 1991	Substantially Equivalent	Midwest Eye Laboratories, Inc.
K791923	SCLERAL POWDER	Jan 10, 1980	Substantially Equivalent	Ocularists , Ltd.