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Portable Non-Contact Tonometer, Model PT100

by Leica Microsystems, Inc. O.I.D.

510(k) K013259

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 NumberK013259 Date20 Feb 2002ClearedStatusActive

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  • Withdrawn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)

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, 23 Sep 2026

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

This device is a portable non-contact tonometer, model PT100, used for measuring intraocular pressure without direct contact with the eye. It is classified as a tonometer, ac-powered, and falls under the ophthalmic medical specialty.

The device received FDA 510(k) clearance (K013259) on February 20, 2002, and is substantially equivalent to a predicate device. It is manufactured by Leica Microsystems, Inc. O.I.D. and is intended for use in clinical settings where ophthalmic tonometry is performed.

Other devices from Leica Microsystems, Inc.

Questions

AI-generated answers, 23 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 PORTABLE NON-CONTACT TONOMETER, MODEL PT100 used for?

    This device is used for measuring intraocular pressure without direct contact with the eye. It is intended for use in clinical settings where ophthalmic tonometry is performed, providing a non-invasive method to assess eye pressure as part of glaucoma screening and monitoring.

  • How is the PORTABLE NON-CONTACT TONOMETER, MODEL PT100 powered and supplied?

    The device is AC-powered, meaning it requires connection to an electrical outlet for operation. It is supplied as a complete, ready-to-use unit designed for placement in clinical environments such as ophthalmology clinics or eye care facilities.

  • Is the PORTABLE NON-CONTACT TONOMETER, MODEL PT100 sterile or single-use?

    The device is not sterile and is not single-use. It is a reusable clinical instrument designed for multiple patient use with appropriate cleaning and disinfection between uses, as it does not come into direct contact with the eye during measurement.

  • What regulatory clearance does the PORTABLE NON-CONTACT TONOMETER, MODEL PT100 have?

    The device received FDA 510(k) clearance (K013259) on February 20, 2002, and is classified as substantially equivalent to a predicate device. This clearance permits its commercial distribution in the United States for the intended use of non-contact intraocular pressure measurement.