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Medart 520 Cooling System

by Medart Corp.

510(k) K000503

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 NumberK000503 Date15 May 2000ClearedStatusActive

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  • Withdrawn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
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
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 Medart 520 Cooling System is a medical device classified under product code GEX, intended for use in surgical procedures requiring temperature control. It is designed to provide localized cooling to tissues, aiding in the reduction of thermal damage and enhancing patient comfort during procedures such as laser surgery or other heat-generating treatments. The system operates by circulating a cooling medium to maintain optimal tissue temperatures, ensuring safe and effective surgical outcomes.

This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as operating rooms or surgical suites. It is not sterile upon delivery and must be sterilized prior to use, adhering to standard medical sterilization protocols. The Medart 520 Cooling System holds an FDA 510(k) clearance (K000503) and was determined to be substantially equivalent to a legally marketed predicate device. No specific MRI safety information is provided in the available data.

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