510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052674Substantially Equivalent

Contact Lens Ophthalmodynamometer

Meditron AS, Golden CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052674 is the FDA 510(k) clearance record for CONTACT LENS OPHTHALMODYNAMOMETER, a class II device, cleared for Meditron, GmbH on under FDA product code NYK (Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)). FDA's definition for product code NYK 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...". FDA records list 4 510(k) clearances for Meditron, GmbH, from to . As of , FDA records show no recalls naming K052674.

Clearance record

Decision date
Received
(239 days to decision)
Product code
NYK Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
Regulation
21 CFR 886.1385
Device class
Class II
Review panel
Ophthalmic
Applicant
Meditron, GmbH 13605 W. 7th Ave., Golden CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NYK

Trailing 12 months

FDA records hold no clearances under product code NYK in the trailing twelve months.

FDA records show no clearances under product code NYK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NYK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260