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510(k) Data Aggregation

    K Number
    K090618
    Device Name
    CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2009-04-14

    (36 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K040727,K060395,K080735
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SmartCool family cold air device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief.

    Device Description

    The SmartCool family cold air device consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.

    AI/ML Overview

    The provided K090618 document for the Cynosure SmartCool family cold air device does not contain information about acceptance criteria or a study proving it meets those criteria.

    This 510(k) summary explicitly states:

    • Nonclinical Performance Data: none
    • Clinical Performance Data: none

    Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Cryo 5 (K040727), Cryo V6 (K060395), and CryoMini (K080735)) by having the "same indications for use, the same principle of operation, and the same performance."

    Therefore, I cannot provide the requested table and details because the submission indicates that no specific performance study was conducted to establish acceptance criteria for this device.

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