DeviceClearance

Product code NYK— Ophthalmic

CONTACT LENS OPHTHALMODYNAMOMETER

Classification name
Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
Device class
Class 2
Regulation
21 CFR 886.1385
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NYK under 21 CFR 886.1385, via openFDA

Market context for product code NYK

FDA has cleared 1 device under product code NYK, all in 2006, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NYK

Recent clearances under product code NYK

Data sourced from openFDA. This site is unofficial and independent of the FDA.