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FOG CONTROL, Lens Fog Reduction Device

by Highpoint Medical Corp.

510(k) K932300

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 NumberK932300 Date17 Sep 1993ClearedStatusActive

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  • Withdrawn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
OCT
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
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 FOG CONTROL, Lens Fog Reduction Device is a medical device designed to reduce lens fogging. It is classified as a Class II device under the FDA's regulatory framework.

The device is supplied as a single-use solution and is intended for use in medical settings. It is not indicated for MRI safety and should be stored according to manufacturer guidelines.

Other devices from Highpoint Medical Corp.

  • Cath Control

    Class II

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 FOG CONTROL Lens Fog Reduction Device used for?

    This device is designed to reduce lens fogging, which can occur during medical procedures. It is intended for use in medical settings.

  • Is the FOG CONTROL device intended for use in MRI environments?

    No, the device is not indicated for MRI safety and should not be used in such environments.

  • How is the FOG CONTROL device supplied?

    The device is supplied as a single-use solution.

  • What are the storage requirements for the FOG CONTROL device?

    The device should be stored according to the manufacturer's guidelines.