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Orthotone

by Orthotone Corp.

510(k) K872111

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 NumberK872111 Date16 Nov 1988ClearedStatusActive

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  • Withdrawn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
HLL
Device Class
Class II
Regulation
21 CFR Part 886.1510
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.

The Orthotone is an Eye Movement Monitor, classified as a device in the ophthalmic medical specialty. It is used to monitor eye movement. The device is a type of monitor.

The Orthotone is supplied with a device class of 2 and is regulated under the regulation number 886.1510. It has been authorized with an FDA 510K clearance. The device has the product code HLL and is associated with the k number K872111.

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 Orthotone used for?

    The Orthotone is used to monitor eye movement, specifically in the ophthalmic medical specialty.

  • What is the regulatory classification of the Orthotone?

    The Orthotone is classified as a device with a class 2 designation and is regulated under the regulation number 886.1510.

  • What type of clearance does the Orthotone have?

    The Orthotone has been authorized with an FDA 510K clearance, indicating it is substantially equivalent to a predicate device.