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510(k) Data Aggregation

    K Number
    K233018
    Device Name
    PICOSECOND Nd:YAG Laser System
    Manufacturer
    IDS, Ltd.
    Date Cleared
    2023-12-21

    (90 days)

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

    IDS, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. - The 1064nm wavelength of the PICOSECOND Nd:YAG Laser System (PICO PREMIUM ) is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). - The 532nm wavelength of the PICOSECOND Nd: YAG Laser System (PICO PREMIUM ) is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzparick skin types I-III.
    Device Description
    The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is comprised of the Main Body which includes an optics laser generator, power supply, cooling system, operation panel, etc., and the Articulated Arm, Handpiece, Foot Switch, Protective Goggles, Power Supply Cord, etc. and by applying high voltage to the laser generator 1064nm and 532nm wavelength and emission wavelength of the laser, the maximum output is 5 00mJ. This device is comprised of an Optical Laser Generator (Optics), power supply, chiller, touch LCD panel and switching mode power supply, main control board, air pump, etc., and is operated by microprocessor software. The Optical Laser Generator (Optics) is comprised of Nd: YAG Rod which is the solid laser medium, Flash lamp for optical generation, various Reflector for optical transmission, etc., and permits high voltage in flash lamp connected with power supply and operates to generate laser energy. After turning on the device, set the Wavelength, Fluence, Frequency, Spot Size, etc. to be used then press the Foot Switch in the READY state, the laser will be energized and transferred through the Articulated Arm and handpiece. A cooling system controls the febrility caused by the laser output.
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    K Number
    K181868
    Device Name
    SHINY RPL System
    Manufacturer
    IDS, Ltd.
    Date Cleared
    2018-10-05

    (85 days)

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

    IDS, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IDS SHINY IPL system is intended for use in Surgical, Aesthetic applications in Dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV. - Wavelengths: Conditions: 415nm - 950nm Acne, Vulgaris 560nm - 950nm Melasma, Ephelides 640nm - 950nm Acne, Hair Reduction 640nm - 1200nm Hair Reduction 695nm - 1200nm Hair Reduction 755nm - 1200nm Hair Reduction
    Device Description
    The SHINY IPL System, using visible rays created by Xenon Lamp through Sapphire which are installed on Hand-piece, and composed Main board, LCD screen, Hand-piece, Cooling system. This device uses computer controlled power supply and filter to generate visible ray pulses of prescribed duration and intensity. This device also equipped the Cooling systems to maintain both the Treatment head / Systems at appropriate and safe temperatures. The visible ray pulses or emission spectra provide therapeutic indications relevant to specific wavelengths emitted from the system. This system has two hand-pieces and each hand-piece has 3 wavelengths to choose from at the end of the Hand-piece there is a sapphire filter. Visible rays are emitted when the button is pressed.
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    K Number
    K180036
    Device Name
    SMAXEL CO2 Surgical Laser System
    Manufacturer
    IDS, LTD.
    Date Cleared
    2018-02-02

    (28 days)

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

    IDS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SMAXEL (formally the MX-7000 MICROXEL) Fractional C02 Laser System is indicated for use in non-fractional mode is incision, excision, ablation, vaporization of human soft tissue. Intended for use in Dermatology, Plastic and General Surgery, Gynecology, Neurosurgery, and Podiatry. When used in fractional mode, the SMAXEL Fractional C02 Laser System indications for use in ablative skin resurfacing, wrinkles, fine lines, rhylides, and furrows in Dermatology, Plastic and General Surgerv,
    Device Description
    SMAXEL CO2 Surgical Laser System
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    K Number
    K171079
    Device Name
    Q-Switched Nd:YAG Laser System
    Manufacturer
    IDS, Ltd.
    Date Cleared
    2017-08-01

    (112 days)

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

    IDS, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Q10 Q-Switched Nd: YAG Laser System is indicated for incision, ablation and vaporization of soft tissue for general dermatology. 1064nm wavelength in Q-switched mode: - Removal of dark ink (black, blue and brown) tattoos - Treatment of nevus of Ota - Treatment of common nevus - Removal or lightening of unwanted hair - Skin resurfacing procedures for the treatment of acne scars and wrinkles 1064nm wavelength in non Q-switched mode: - Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9, and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin - Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins - Coagulation and hemostasis of soft tissue - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris 532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650mm with the optional 585nm and 650nm dye hand-piece): - Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos - Treatment of vascular lesions including, but not limited to: - port wine birthmarks - telangiectasias - spider angioma - cherry angioma - spider nevus - Treatment of pigmented lesions including, but not limited to: - café-au-lait birthmarks - solar lentigines - senile lentigines - Becker's nevus - freckles - common nevus - nevus spilus - Treatment of seborrheic keratosis - Treatment of post inflammatory hyperpigmentation - Skin resurfacing procedures for the treatment of acne scars and wrinkles
    Device Description
    Not Found
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