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Dermal Cooling System

by R2 Technologies, Inc. United States 510(k)

510(k) K201260

Product code GEH

Overview

The Dermal Cooling System is a medical device used for cooling the skin. It is classified as a device with a product code of GEH and a regulation number of 878.4350.

The Dermal Cooling System is supplied by R2 Technologies, Inc. and has been cleared by the FDA with a 510K clearance. It is intended for use in general and plastic surgery settings, and its storage and use are subject to the manufacturer's instructions. The device has a specific set of registration numbers and fei numbers associated with it.

Summary written by AI from registry data, 24 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201260 Date24 Sep 2020ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

510(k) · synced 23 Oct 2026

510(k) Number
FDA Product Code
GEH
Device Class
Class II
Regulation
21 CFR Part 878.4350
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from R2 Technologies, Inc.

See all devices from R2 Technologies, Inc. →

Questions

  • What is the Dermal Cooling System used for?

    The Dermal Cooling System is used for cooling the skin in general and plastic surgery settings.

  • Is the Dermal Cooling System cleared by the FDA?

    Yes, the Dermal Cooling System has been cleared by the FDA with a 510K clearance, indicating it is substantially equivalent to a predicate device.

  • What are the storage and use instructions for the Dermal Cooling System?

    The storage and use of the Dermal Cooling System are subject to the manufacturer's instructions, which should be followed carefully to ensure safe and effective use.

  • What is the product code for the Dermal Cooling System?

    The product code for the Dermal Cooling System is GEH, and it is classified under regulation number 878.4350.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K201260 24 fields · synced 23 Oct 2026