FDA product code NYK

Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

Ophthalmic·Class 2·21 CFR 886.1385
US regulatory classifications
US Product Code (FDA)
NYK
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 886.1385
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Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma) is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.