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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device camera, ophthalmic, general-use
Regulation Description Ophthalmic camera.
Definition PJZ cameras are prescription devices indicated only for the capture and storage of images of the eye and surrounding area in the general population. PJZ cameras cannot be indicated for any specific population (e.g., pediatrics, AMD patients, etc.), cannot contain any type of “diagnostic” or “aid in diagnosis” claims in the indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for Ophthalmic Instruments.
Product CodePJZ
Regulation Number 886.1120
Device Class 2