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Pantops M-2 Electrophysiology System

by Visidyne Corp.

510(k) K810699

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 NumberK810699 Date9 Jun 1981ClearedStatusActive

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  • Withdrawn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
HLX
Device Class
Class II
Regulation
21 CFR Part 886.1630
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Pantops M-2 Electrophysiology System is a photostimulator, AC-powered device classified under ophthalmic medical specialty. It is designed for use in electrophysiology applications involving light-based stimulation of biological samples.

The system is supplied as a reusable, AC-powered device intended for use in clinical or laboratory settings. It has received FDA 510(k) clearance (K810699) and is classified as a Class II device under regulation number 886.1630. No information regarding sterility, MRI safety, specific sizes, or storage conditions is provided in the data.

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