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510(k) Data Aggregation

    K Number
    K080915
    Device Name
    FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Date Cleared
    2008-07-01

    (90 days)

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

    RELIANT TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fraxel re:pair (Fraxel III SR) Laser System, including its resurfacing handpiece delivery system, is intended for use in: -Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. -Treatment of wrinkles, rhytides, furrows, fine lines; -Pigmented lesions; -Textural irregularities; -Vascular dyschromia. The Fraxel re:pair (Fraxel III SR) Laser System, including its incisional and debulking delivery systems, are intended for ablation (removal), for the reduction, treatment and/or removal of: - Actinic and seborrheic keratoses; -Chelitis; -Cutaneous horns; -Hemangiomas; -Keloids; -Nevi, including spider, epidermal and protruding; -Rhinophyma; -Syringomas; -Warts; -Laser incision and/or excision for the performance of upper and lower eyelid blepharoplasty and vermilionectomy of the lip.
    Device Description
    The Fraxel re:pair Laser System consists of a CO2 laser source and three delivery handpieces for resurfacing, incision and debulking procedures. Each handpiece attaches to an articulating arm. Additional device accessories include interchangeable resurfacing treatment tips, incisional handpiece spatulas, and debulking handpiece spatulas.
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    K Number
    K071051
    Device Name
    FRAXEL III SR LASER SYSTEM AND ACCESSORIES
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Date Cleared
    2007-11-02

    (203 days)

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

    RELIANT TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fraxel III SR Laser System and accessories is intended for use in: Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
    Device Description
    The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.
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    K Number
    K071621
    Device Name
    RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Date Cleared
    2007-10-09

    (117 days)

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

    RELIANT TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Skin cooling in conjunction with drinatological laser treatments to reduce pain and thermal damage to skin tissue.
    Device Description
    The C300 Chiller System is a thermoelectric cooler (TECs) which utilizes the Peltier effect. The chiller employs solid-state heat pumps that cool thermoelectrically and contain no moving parts. The C300 Chiller System is contained within a single housing. The chiller console is electrically connected to a standard 110 VAC wall outlet. The unit delivers low temperature air at an adjustable rate through a treatment tube. The user interacts with the C300 Chiller System by turning the power switch to the on position and selecting the desired temperature via the display on the digital controller
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    K Number
    K070284
    Device Name
    FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM)
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Date Cleared
    2007-05-17

    (108 days)

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

    RELIANT TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fraxel® SR 1500 Laser System and accessories is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of acne scars and surgical scars; Photocoagulation for treatment of dyschromia and pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis and melasma; Skin resurfacing procedures.
    Device Description
    The Fraxel® SR1500 Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. 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
    K063038
    Device Name
    FRAXEL III SR LASER SYSTEM AND ACCESSORIES
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Date Cleared
    2007-04-27

    (207 days)

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

    RELIANT TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fraxel III SR Laser System and accessories is intended for use in: Dermatological procedures requiring ablation (removal), coagulation and resurfacing of soft tissue.
    Device Description
    The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.
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    K Number
    K063808
    Device Name
    FRAXEL IV SR LASER SYSTEM
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Date Cleared
    2007-04-27

    (126 days)

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

    RELIANT TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fraxel IV SR Laser System and accessories is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of acne scars and surgical scars; Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia; Skin resurfacing procedures.
    Device Description
    The Fraxel IV SR Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the skin.
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    K Number
    K062303
    Device Name
    FRAXEL II SR LASER SYSTEM
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Date Cleared
    2007-01-31

    (176 days)

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

    RELIANT TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fraxel II SR Laser System and accessories is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of acne scars and surgical scars; Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia; Skin resurfacing procedures.
    Device Description
    The Fraxel II SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
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    K Number
    K060310
    Device Name
    FRAXEL II SR LASER SYSTEM AND ACCESSORIES
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Date Cleared
    2006-03-29

    (50 days)

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

    RELIANT TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia; Skin resurfacing procedures.
    Device Description
    The Fraxel II SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
    Ask a Question
    K Number
    K053047
    Device Name
    FRAXEL SR LASER SYSTEM
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Date Cleared
    2006-03-20

    (143 days)

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

    RELIANT TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reliant Laser System II and accessories (Fraxel SR Laser System) is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of surgical scars and acne scars; Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia; Skin resurfacing procedures.
    Device Description
    The Fraxel SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments.
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    K Number
    K050841
    Device Name
    FRAXEL SR LASER SYSTEM
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Date Cleared
    2005-07-05

    (95 days)

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

    RELIANT TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reliant Laser System II is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia; Skin resurfacing procedures.
    Device Description
    The Fraxel SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments.
    Ask a Question

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