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510(k) Data Aggregation

    K Number
    K101490
    Device Name
    FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2010-09-08

    (99 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1550 nm: The Fraxel re:store 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars. 1927 nm: The Fraxel re:store 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis.
    Device Description
    The Fraxel re:store® Dual Laser System consists of a 1550 nm laser source and a 1927 nm laser source with fiber delivery and control by an embedded processor for use in dermatological procedures. The laser system uses scanning and focusing optics to deliver a controlled pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
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    K Number
    K072849
    Device Name
    MODIFICATION TO THERMAGE THERMACOOL SYSTEM
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2008-01-18

    (106 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis. Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids. Non-invasive treatment of wrinkles and rhytids. Temporary improvement in the appearance of cellulite. Relief of minor muscle aches and pains. Relief of muscle spasms. Temporary improvement of local circulation (i.e., blood circulation)
    Device Description
    The Multiplex Assembly is a 4-electode design incorporating four 3.00-cm electrode footprints with required spacing. The tip is fabricated from the same materials as the previous tips, with the addition of a ceramic coolant spreader. Tip fabrication will be performed in the same manner and the treatment procedure will be similar to previous methods. The Handpiece, Coupling Fluid, Return Pad and Skin Marking Paper have been modified to accommodate the larger tip dimensions.
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    K Number
    K052936
    Device Name
    THERMAGE THERMACOOL SYSTEM
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2007-06-12

    (601 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermage ThermaCool System is indicated for use in: - Dermatologic and general surgical procedures for electro coagulation and hemostasis, - Non-invasive treatment of periorbital wrinkles and rhytids including the upper and lower eyelids - Non-invasive treatment of facial wrinkles and rhytids
    Device Description
    The Thermage ThermaCool System consists of the following components: - ThermaCool System . - Handpiece Assembly (consisting of Handpiece and Treatment Tip) ● - Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin ● Marking Paper - Accessory cables and tubing - Optional footswitch component ●
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    K Number
    K061001
    Device Name
    THERMASSAGE
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2006-10-12

    (184 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TherMassager is indicated for use in: - Relief of minor muscle aches and pains - Relief of muscle spasm - Temporary improvement of local circulation (i.e., blood circulation) - Temporary improvement in the appearance of cellulite
    Device Description
    The TherMassager is a self-contained, 9.0 VIDC electrically powered therapeutic massager. The basic configuration is that of an ergonomically rounded hand-held box-like unit. Weight is approximately 4 pounds. The housing is made from medical grade plastic and contains a suction pump, a massage motor and skin rollers. The outside of the unit is affixed with a strap which may be secured over the operators hand to provide additional grip during treatment application. Three treatment rollers are supplied with each unit. The TherMassager unit has I spiral roller, 1 ribbed roller and 1 lobed (contoured) roller. The rollers are made from medical grade silicone elastomer meeting ISO 10993 biocompatibility standards.
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    K Number
    K053365
    Device Name
    MODIFICATION TO THERMAGE THERMACOOL SYSTEM
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2005-12-13

    (11 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermage ThermaCool System is indicated for use in: - Dermatologic and general surgical procedures for electro coagulation and hemostasis - Non-invasive treatment of wrinkles and rhytids
    Device Description
    This special 510(k) application covers a system identical to the earlier devices and clearances. The Thermage ThermaCool System consists of the following components: *RF Generator *Cooling Module *Cryogen Canister *Handpiece Assembly (consisting of Handpicce and Treatment Tip) * Accessory cables and tubing *Optional footswitch component * Accessories: coupling fluid, return pad and skin marking paper
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    K Number
    K052778
    Device Name
    THERMAGE THERMACOOL SKIN MARKETING
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2005-10-20

    (17 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermage ThermaCool System is indicated for use in: - Dermatologic and general surgical procedures for electro coagulation and hemostasis, - Non-invasive treatment of periorbital wrinkles and rhytids . - Non-invasive treatment of facial wrinkles and rhytids .
    Device Description
    The Thermage ThermaCool System consists of the following components: - ThermaCool System . - Handpiece Assembly (consisting of Handpiece and Treatment Tip) . - Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper - Accessory cables and tubing . - Optional footswitch component .
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    K Number
    K051710
    Device Name
    THERMAGE THERMACOOL COUPLING FLUID
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2005-07-19

    (22 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermage ThermaCool System is indicated for use in: - Dermatologic and general surgical procedures for electro coagulation and u hemostasis, - Non-invasive treatment of periorbital wrinkles and rhytids u - Non-invasive treatment of facial wrinkles and rhytids
    Device Description
    The Thermage ThermaCool System consists of the following components: - ThermaCool System . - Handpiece Assembly (consisting of Handpiece and Treatment Tip) ● - Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper - Accessory cables and tubing . - Optional footswitch component .
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    K Number
    K043402
    Device Name
    THERMAGE THERMACOOL SYSTEM
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2005-01-14

    (35 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermage ThermaCool System is indicated for use in: - The Thermage ThermaCool System is indicated for use in . and General Surgical procedures for Dermatologic electrocoagulation and hemostasis. - Non-invasive treatment of periorbital wrinkles and rhytids. . - Non-invasive treatment of facial wrinkles and rhytids. .
    Device Description
    The Thermage ThermaCool System consists of the following components: - ThermaCool System ● - Handpiece Assembly (consisting of Handpiece and Treatment Tip) . - Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper - Accessory cables and tubing . - Optional footswitch component .
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    K Number
    K040135
    Device Name
    THERMAGE THERMACOOL SYSTEM
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2004-06-21

    (151 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermage ThermaCool System is indicated for use in: - Dermatologic and general surgical procedures for electro coagulation and hemostasis, - Non-invasive treatment of periorbital wrinkles and rhytids - Non-invasive treatment of facial wrinkles and rhytids
    Device Description
    The Thermage ThermaCool System consists of the following components: - RF Generator . - Cooling Module ● - Cryogen Canister . - Handpiece Assembly (consisting of Handpiece and Treatment Tip) . - Accessory cables and tubing . - Optional footswitch component . - Accessories: coupling fluid, return pad and skin marking paper . The Handpiece Assembly and Cooling Module connect to the RF Generator.
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    K Number
    K033942
    Device Name
    THERMAGE THERMACOOL SYSTEM
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2004-02-04

    (47 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis. Non-invasive treatment of periorbital wrinkles and rhytids.
    Device Description
    The Thermage ThermaCool System consists of the following components: - ThermaCool System . - Handpiece Assembly (consisting of Handpiece and Treatment Tip) . - Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper - Accessory cables and tubing . - Optional footswitch component ●
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