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510(k) Data Aggregation

    K Number
    K152856
    Device Name
    Helios III
    Manufacturer
    LASEROPTEK CO. LTD.
    Date Cleared
    2016-06-02

    (247 days)

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

    LASEROPTEK CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) port wine birthmarks (532 nm) telangiectasias (532 nm) spider angioma (532 nm) cherry angioma (532 nm) spider nevi (532 nm) cafe-au-lait birthmarks (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles, nevus spilus (532 mm) nevus of ota (1064 nm)
    Device Description
    The Helios III laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Nd–YAG crystal – a gain medium – and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit. The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.
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    K Number
    K083253
    Device Name
    LOTUS II PULSED ER: YAG LASER SYSTEM
    Manufacturer
    LASEROPTEK CO. LTD.
    Date Cleared
    2009-05-15

    (192 days)

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

    LASEROPTEK CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lotus II Pulsed Er:YAG Laser System is a pulsed erbium doped yttrium-aluminum-garnet (Er:YAG) laser. It outputs laser light with a wavelength of 2940 nm, a wavelength very efficiently absorbed by the skin. It is intended for coagulation, vaporization, ablation and/or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and ophthalmology (skin around the eyes). This includes skin resurfacing and the treatment of wrinkles The Lotus II Er:YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
    Device Description
    The Lotus II laser system is an Erbium:YAG laser with a wavelength of 2.94 um. Laser activation is by footswitch. Three basic elements of operations are as follows: 1) A Er:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Er:YAG crystal – a gain medium – and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit.
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    K Number
    K083203
    Device Name
    HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM
    Manufacturer
    LASEROPTEK CO. LTD.
    Date Cleared
    2009-04-28

    (180 days)

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

    LASEROPTEK CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Incision, excision, ablation, vaporization of soft tissue for general dermatology. Removal or lightening of unwanted hair with or without adjuvant preparation. Tattoo Removal - dark ink: blue and black . - light ink. red - light ink: sky blue - light ink: green Treatment of Vascular Lesions: - port wine birthmarks - telangiectasias . - spider angioma - cherry angioma . - spider nevi Treatment of Pigmented Lesions: - café-au-lait birthmarks . - solar lentiginos . - senile lentiginos . - becker's nevi - freckles - nevus spilus - nevus of ota
    Device Description
    The Helios II® laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Nd:YAG crystal - a gain medium - and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit. The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.
    Ask a Question

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