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510(k) Data Aggregation

    K Number
    K213294
    Device Name
    Dermal Cooling System
    Manufacturer
    R2 Technologies, Inc.
    Date Cleared
    2022-11-10

    (405 days)

    Product Code
    QPZ, GED, ILO
    Regulation Number
    878.4340
    Why did this record match?
    Product Code :

    QPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling. inflammation, and hematoma from minor surgical procedures. The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections. When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal. The Dermal Cooling System is intended to be used by trained healthcare professionals.
    Device Description
    The 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 and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. For dermabrasion, the Dermal Cooling System handpiece is intended to serve as a handle to facilitate manual movement of the R2 Dermabrasion Tips. The R2 Dermabrasion Tips are optional accessories for the Dermal Cooling System that may be attached to the distal end of the handpiece to facilitate manual dermabrasion. The R2 Dermabrasion Tips may be used with a commercially available topical or water to facilitate movement of the handpiece across the treatment area.
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    K Number
    K203006
    Device Name
    R2 Dermabrasion Tip (for Dermal Cooling System)
    Manufacturer
    R2 Technologies, Inc.
    Date Cleared
    2021-08-05

    (308 days)

    Product Code
    QPZ, GED
    Regulation Number
    878.4340
    Why did this record match?
    Product Code :

    QPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal. The Dermal Cooling System is intended to be used by trained healthcare professionals.
    Device Description
    The 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 and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. For dermabrasion, the Dermal Cooling System handpiece is intended to serve as a handle to facilitate manual movement of the R2 Dermabrasion Tips. The R2 Dermabrasion Tips are optional accessories for the Dermal Cooling System that may be attached to the distal end of the handpiece to facilitate manual dermabrasion. The R2 Dermabrasion Tips may be used with a commercially available topical or water to facilitate movement of the handpiece across the treatment area.
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