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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device camera, ophthalmic, non-prescription
Definition Non-prescription ophthalmic camera is an AC or battery-powered device intended to take photographs of the eye and the surrounding area. The device is intended to be operated by a lay person and provide images available for evaluation by an eye care professional.
Product CodeQZP
Regulation Number 886.1120
Device Class 2