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Contact Lens Ophthalmodynamometer

by Meditron, GmbH

510(k) K052674

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052674 Date24 May 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NYK
Device Class
Class II
Regulation
21 CFR Part 886.1385
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Contact Lens Ophthalmodynamometer is a diagnostic contact lens constructed from polymethylmethacrylate. It functions as a Goldmann three-mirror examination glass adapted with precision electronic sensors to provide continuous measurement of pressure applied to the eye.

This device utilizes electronic signals from its sensors to determine pressure values, which are displayed on an integrated LCD. It is classified as a Class 2 medical device under regulation 886.1385 and has received FDA 510(k) clearance under K052674.

Other devices from Meditron Corp.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Contact Lens Ophthalmodynamometer?

    This device is a diagnostic contact lens designed to provide continuous measurement of pressure applied to the eye. It functions as a Goldmann three-mirror examination glass equipped with precision electronic sensors that transmit data to an integrated LCD screen.

  • What material is used to construct this diagnostic lens?

    The device is constructed from polymethylmethacrylate, a durable material commonly used in ophthalmic diagnostic equipment to ensure clarity and structural integrity during examinations.

  • What is the regulatory status of this device?

    The Contact Lens Ophthalmodynamometer is classified as a Class 2 medical device under regulation 886.1385. It has received FDA 510(k) clearance under K052674, confirming it is substantially equivalent to legally marketed predicate devices.