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510(k) Data Aggregation

    K Number
    K121162
    Device Name
    POLARIS Q-SWITCH RUBY SYSTEM
    Manufacturer
    SANDSTONE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2012-07-18

    (92 days)

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

    SANDSTONE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polaris Long Pulse and Q-Switched Ruby Laser is intended to remove blue/black tattoos and benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
    Device Description
    The Polaris Long Pulse and Q-Switched Ruby Laser and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Energy is delivered using an articulated arm with interchangeable handpieces to adjust spot size. The wavelength is 694.3nm. The user activates laser by means of a footswitch.
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    K Number
    K110897
    Device Name
    CORTEX CO2 / ER:YAG LASER SYSTEM
    Manufacturer
    SANDSTONE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2011-07-01

    (93 days)

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

    SANDSTONE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CO2 laser is indicated for coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology. The Er: YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
    Device Description
    The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. There is an additional Er: YAG handpiece that attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.
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    K Number
    K110502
    Device Name
    TRIPLEX ER. YAG / ND: YAG SYSTEM
    Manufacturer
    SANDSTONE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2011-04-27

    (64 days)

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

    SANDSTONE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery). The Nd:YAG handpiece is indicated for: - At the 1064nm wavelength dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair. - At the 532nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial telangiectasias, as, angiomas, and leg veins, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)
    Device Description
    The Apex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. There are 2 handpieces with the system. One is an Er:YAG laser which contains the laser cavity in the head of the handpiece. The second is an Intense Pulsed Light. These handpieces can be removed by the user and interchanged. The Er:YAG Laser energy is a wavelength of 2940nm. This handpiece can be removed and replaced with a q-switch Nd:YAG handpeice emitting wavelengths of 1064nm and 532nm laser energy can be added. The user activates the laser emission by means of a footswitch.
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    K Number
    K100893
    Device Name
    CHEVEUX DIODE LASER SYSTEM
    Manufacturer
    SANDSTONE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2010-06-16

    (77 days)

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

    SANDSTONE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cheveux Diode Laser System is indicated for: Hair Removal Permanent hair reduction Treatment of vascular lesions Treatment of benign pigmented lesions Treatment of Leg Veins Treatment for pseudofolliculitis barbae The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin
    Device Description
    The Cheveux Diode Laser System delivers laser light with an 810 nm wavelength. The system consists of a console and a handpiece connected to the system by an umbilical. Energy output is initiated with trigger on the handpiece.
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    K Number
    K093793
    Device Name
    LS-40 CO2 LASER SYSTEM MODEL LS-40
    Manufacturer
    SANDSTONE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2010-02-18

    (70 days)

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

    SANDSTONE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
    Device Description
    The LS-40 CO2 Laser System is a microprocessor- controlled CO2 laser system using a sealed CO2 laser tube providing 40 watts maximum power. The system incorporates a CO2 laser tube within the main cabinet, an articulated arm beam delivery system and attachable laser accessories. The unit is activated for laser emission by a footswitch.
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    K Number
    K082407
    Device Name
    MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM
    Manufacturer
    SANDSTONE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2009-02-03

    (166 days)

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

    SANDSTONE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented lesions . and the removal or lightening of hair. - At the 532 nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)
    Device Description
    The UltraLight II Nd: Y AG Laser System consists of a power supply unit with cooling, a footswitch and an umbilical cord that connects to the laser, which is located in the handpiece. In standard use, the handpiece is held against the treatment area dn the light pulse is delivered when the footswitch is depressed. Laser parameters and other system features are controlled from the display panel located on the front of the power supply unit.
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    K Number
    K082101
    Device Name
    LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE
    Manufacturer
    SANDSTONE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2008-11-05

    (103 days)

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

    SANDSTONE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The scanning handpiece is intended to be used as an accessory to the LS Family of CO2 Lasers to deliver the laser light to the targeted area for skin resurfacing in a fractionated manner.
    Device Description
    The LS Family of CO2 lasers are microprocessor-controlled laser systems that incorporate a handpiece to deliver energy to the tissue in a scanned, fractionated pattern.
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    K Number
    K081219
    Device Name
    APOLLO MINI IPL SYSTEM
    Manufacturer
    SANDSTONE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2008-06-30

    (61 days)

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

    SANDSTONE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apollo Mini-IPL System is indicated for use skin types I-IV according to the Fitzpatrick Scale for the following indications: Hair Removal (650nm filter), Permanent hair reduction (650nm filter), Treatment of vascular lesions (510nm filter), Treatment of benign pigmented lesions (510nm filter), Mild to Moderate inflammatory acne (450nm filter).
    Device Description
    The Apollo Mini IPL System delivers pulsed light at wavelengths starting at 450-1200nm nanometers. The device consists of the cabinet, which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide.
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    K Number
    K041011
    Device Name
    ULTRALIGHT II ND:YAG LASER SYSTEM
    Manufacturer
    SANDSTONE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2004-12-14

    (238 days)

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

    SANDSTONE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    At the 1064 nm wavelength dark ink tattoo removal of pigmented lesions . and the removal or lightening of hair. and the Femoval of ifgifteding of help of red ink tattoos, treatment of vascular hesions . including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)
    Device Description
    The UltraLight II Nd:YAG Laser System consists of a power supply unit with cooling, a footswitch and an umbilical cord that connects to the laser, which is located in the bandpiece. In standard use, the handpiece is held against the treatment area dn)the light pulse is delivered when the footswitch is depressed. Laser parameters and other system features are controlled from the display panel located on the front of the power supply unit.
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    K Number
    K040563
    Device Name
    LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)
    Manufacturer
    SANDSTONE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2004-10-08

    (219 days)

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

    SANDSTONE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
    Device Description
    The LS Family of CO2 Lasers are microprocessor-controlled CO2 laser systems using a sealed CO2 laser tube providing either 15 watts maximum power (LS-15 ) or 25 watts maximum power (LS-25). The system incorporates a CO2 laser tube within the main cabinet, an articulated arm beam delivery system and attachable laser accessories. The unit is activated for laser emission by a footswitch.
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