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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State The contact lens consists of a curved shell of acrylic plastic (PMMA), which is adapted with electronic sensors for measurement of pressure applied to the eye. The pressure values are displayed on a LCD display.
Technical Method The examination PMMA contact lens is adapted with electronic sensors for measurement of pressure applied to the eye. The pressure values are displayed on a LCD display.
Target Area Eye
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeNYK
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type 510(k)
Regulation Number 886.1385
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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