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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ophthalmodynamometer, diagnostic contact lens, polymethylmethacrylate (pmma)
Regulation Description Polymethylmethacrylate (PMMA) diagnostic contact lens.
Definition Pmma diagnostic contact lens ophthalmodynamometer is intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis of intraocular abnormalities. The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.
Product CodeNYK
Regulation Number 886.1385
Device Class 2