Product code NYK

Device name
Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
Medical specialty
Ophthalmic
Device class
2
Regulation number
886.1385
Review panel
OP
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
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.
Source
FDA openFDA device classification dataset