BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Dermal Cooling System

    K Number: K213294 · Decision Nov 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    3
    Review Days
    405

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    Basic Information

    Device Name
    Dermal Cooling System
    K Number
    K213294
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4340
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R2 Technologies, Inc.
    Date Received
    October 1, 2021
    Decision Date
    November 10, 2022
    Product Code
    QPZ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QPZ Contact Cooling For Skin Lesion Pain Relief

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QPZ), ordered by most recent decision date.

    R2 Dermabrasion Tip (for Dermal Cooling System)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by R2 Technologies, Inc.

    K Number Device Name
    K203006 R2 Dermabrasion Tip (for Dermal Cooling System)
    K201260 Dermal Cooling System