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Woodlyn Applanation Tonometer

by Woodlyn, Inc. 510(k)

Active United States

510(k) K841762

Overview

The Woodlyn Applanation Tonometer is an AC-powered ophthalmic device designed to measure intraocular pressure. It functions by applanating the cornea to determine the force required to flatten a specific area, providing essential data for clinical eye examinations.

This device is regulated as a Class II medical device under product code HKX and regulation number 886.1930. It received FDA 510(k) clearance on August 2, 1984, under submission number K841762.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK841762 Date2 Aug 1984ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HKX
Device Class
Class II
Regulation
21 CFR Part 886.1930
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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