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    K Number
    K072048
    Device Name
    LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE
    Manufacturer
    LYNTON LASERS LIMITED
    Date Cleared
    2007-11-16

    (114 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LYNTON LASERS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a desk-top device used for the treatment of chronic pain by emitting energy in the near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a high intensity lamp intended for various pain relief type applications by emitting light in the wavelength range 650-690nm (near-IR) with fluences of order 10-100mW/cm². The principle parts of the system comprise of a desktop base unit and a Fibre Optic Probe (FOP) delivery system. The base unit contains a mains supplied power supply unit which powers a 250W halogen bulb, the duration of the illumination being controlled by a timing pcb with user-accessible controls. The FOP delivery system comprises of a ruggedised fibre bundle assembly and (crucially) an optical filter which selectively transmits only the therapeutic near-IR light. A mechanical fixture is also optionally available for holding the output of the FOP delivery system at an adjustable distance and direction relative to the skin treatment area.
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    K Number
    K063427
    Device Name
    LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM
    Manufacturer
    LYNTON LASERS LIMITED
    Date Cleared
    2007-07-25

    (254 days)

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

    LYNTON LASERS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LUMINA Intense Pulsed Light (& Laser) System is intended for use in applications requiring the selective ablation, vaporization and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialities of general & plastic surgery and dermatology. The LUMINA Intense Pulsed Light (& Laser) System, when using the IPL Handpieces, is indicated for: - The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation and ephelides (freckles). - The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. - The removal of unwanted hair and to effect stable long-term or permanent hair removal. - Indicated for use on all skin types (Fitzpatrick I-IV) The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 1064nm (Long Pulsed and Q-Switched), is indicated for treatment and clearance of: - Benign vascular lesions such as, but not limited to treatment of: - Port wine stains - Hemangiomas - Superficial and deep telangiectasias (venulectasias) - Reticular veins (0.1 - 4.0mm diameter) of the leg - Rosacea - Venus Lake - Leg veins - Spider veins - Poikiloderma of Civatte - Angiomas - The removal of blue or black tattoos (significant reduction in the intensity of black and/or blue/black tattoos) - The non-ablative treatment of facial wrinkles, such as, but not limited to: - Periocular wrinkles - Perioral wrinkles - The removal of unwanted hair, for stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. - Removal or lightening of unwanted hair (with and without adjuvant preparation). - Pseudofolliculitis barbae (PFB) - Indicated for use on all skin types (Fitzpatrick I-IV) The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 532nm (Long Pulsed and Q-Switched), is indicated for: - Tattoo removal: - Light blue - Yellow - Red - Benign pigmented lesions such as, but not limited to: - Café au lait macules - Lentigines (senile and solar) - Freckles (ephelides) - Chloasma - Nevi - Nevus spillus - Nevus of Ota - Becker's nevi
    Device Description
    The LUMINA Intense Pulsed Light (& Laser) System is a platform for a range of Intense Pulse Light (IPL) Handpieces and an internal Nd:YAG Laser Accessory for a number of applications in general and plastic surgery and dermatology. The System includes: - A floor-standing main cabinet unit (including the central control electronics) that controls timing and dosing parameters. This unit also contains a water-cooling system used to remove heat from the IPL Handpieces and the internal Nd:YAG Laser Accessory (if fitted). - A control and display panel including a touchscreen. - A range of optional IPL handpieces that include the flashlamp light source, electrical and cooling water connections.
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    K Number
    K062871
    Device Name
    LUMACARE LC-122M NON-COHERENT LIGHT SOURCE
    Manufacturer
    LYNTON LASERS LIMITED
    Date Cleared
    2006-11-14

    (50 days)

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

    LYNTON LASERS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LumaCare LC-122M Non-coherent Light Source is intended to provide therapeutic light to the body. The LumaCare LC-122M Non-coherent Light Source is generally indicated to treat dermatological conditions. The LumaCare LC-122M Non-coherent Light Source is specifically indicated to treat moderate inflammatory acne vulgaris.
    Device Description
    The LumaCare LC-122M Non-coherent Light Source is a high intensity lamp intended for the therapy of dermatological disorders such as moderate inflammatory acne vulgaris by emitting visible light in the wavelength range 400-440nm (blue) with fluences of order 10-100mW/cm². The principle parts of the system comprise of a desktop base unit and a Fibre Optic Probe (FOP) delivery system. The base unit contains a mains supplied power supply unit which powers a 250W halogen bulb, the duration of the illumination being controlled by a timing pcb with user-accessible controls. The FOP delivery system comprises of a ruggedised fibre bundle assembly and (crucially) an optical filter which selectively transmits only the therapeutic blue light. A mechanical fixture is also optionally available for holding the output of the FOP delivery system at an adjustable distance and direction relative to the skin treatment area.
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