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Diaton Tonometer

by Ryazan State Instruments

510(k) K060780

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060780 Date6 Apr 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Tonometer Diaton
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

Overview

AI-generated summary, 1 Oct 2026

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

The Diaton Tonometer is an Ac-Powered Tonometer designed for intraocular pressure (IOP) measurement. Classified under the Ophthalmic medical specialty, it operates non-invasively by assessing pressure through the eyelid, eliminating direct contact with the cornea. This device aids in the early detection of glaucoma and supports clinical decision-making for appropriate treatment planning.

Used in ophthalmic settings, the Diaton Tonometer is a reusable, non-sterile diagnostic tool with no MRI safety restrictions as noted in regulatory filings. Supplied as a single unit, it requires standard electrical power and is regulated under FDA 510(k) clearance (K060780) with a classification of Class II. Storage conditions are not specified but follow general medical device guidelines. The device’s design ensures patient comfort and reduces infection risk by avoiding corneal contact or anesthesia.