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510(k) Data Aggregation

    K Number
    K161480
    Device Name
    R2 Dermal Cooling System
    Manufacturer
    R2 Dermatology
    Date Cleared
    2016-10-05

    (127 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K110754,K152133
    Why did this record match?
    Device Name :

    R2 Dermal Cooling System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The R2 Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin.

    Device Description

    The R2 Dermal Cooling System is a cryosurgical device used to cool the skin, without the use of cryogenic gases or liquids, for the removal of benign skin lesions. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. It is intended for use in a healthcare facility such as a clinic or doctor's office.

    The Dermal Cooling System is comprised of the following components:

    • control unit - houses the user interface, the system controller, and the power source
    • handpiece – contains the TEC, thermistors, and the aluminum cooling plate in a thermoplastic housing
    • chiller - provides circulating water to the handpiece to remove heat extracted by the TEC
    • isolation transformer – isolates system from AC power
    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the R2 Dermal Cooling System, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criteria (Implicit or Explicit in Document)Reported Device Performance (as stated in document)
    BiocompatibilitySkin contacting, surface device for limited duration (
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