Product Code: HPG FDA class 1 21 CFR 886.5900

Aid, Vision, Electronic, Battery-Powered

Ophthalmic

A Battery-Powered Electronic Vision Aid is a portable device that uses electronic imaging and display technology to magnify and enhance visual content for individuals with low vision, providing portable assistance for reading and visual tasks away from a fixed power source. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket submission. It carries product code HPG and is regulated under 21 CFR 886.5900, within the Ophthalmic medical specialty.

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FEI Numbers

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Basic Information

Product Code: HPG
Device Class: FDA class 1
Regulation Number: 886.5900
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 7 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K910601	PATHFINDER	May 14, 1991	Substantially Equivalent	Nurion Industries
K910124	LOW VISION ENHANCEMENT SYSTEM (LVES)	Apr 10, 1991	Substantially Equivalent	Triangle Investments
K903558	LASER CANE	Sep 27, 1990	Substantially Equivalent	Nurion Industries
K902187	POLARON	Aug 08, 1990	Substantially Equivalent	Nurion Industries
K862338	SENSORY 6	Sep 03, 1986	Substantially Equivalent	Brytech, Inc.
K823385	ALES	Mar 09, 1983	Substantially Equivalent	Oms
K761215	F4912 NIGHT VISION AID	Dec 16, 1976	Substantially Equivalent	Itt Corp.