NYKClass II

Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

21 CFR 886.1385 / Ophthalmic

NYK is the FDA product code for Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma), a class II device type, regulated under 21 CFR 886.1385. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2006-05-24, and no recalls.

Classification record

Product code: NYK
Device name: Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
FDA 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.
Regulation: 21 CFR 886.1385
Device class: Class II
Review panel: Ophthalmic
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code NYK

By decision year

1 clearance under product code NYK with a decision year between 2006 and 2006, 2006 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code NYK by decision year
Year	Clearances
2006	1

Applicants with the most clearances

Product code NYK

Applicants holding the most 510(k) clearances under product code NYK
Applicant	Clearances
Meditron AS	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NYK.

Recent clearances

Product code NYK

K052674Class IIContact Lens OphthalmodynamometerMeditron, GmbH / cleared 2006-05-24

Recent recalls

Product code NYK

FDA records show no recalls under product code NYK.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)