NYK · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1385
Classification
FDA Product Code
NYK
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 886.1385
Review panel
OP
Medical specialty
Ophthalmic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.