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Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

FDA product code NYK · 1 cleared devices

Class 2 Ophthalmic
Regulation
21 CFR 886.1385
Review panel
OP
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2006-05-24 – 2006-05-24

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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