NYK

Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

Product code

NYK

Device name

Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

Device class

Class 2

21 CFR

21 CFR 886.1385

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).