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510(k) Data Aggregation

    K Number
    K033251
    Device Name
    THE FRIENDLYLIGHT ND: YAG LASERS
    Manufacturer
    INNOTECH USA, INC.
    Date Cleared
    2004-03-02

    (147 days)

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

    INNOTECH USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FriendlyLight® Nd: YAG lasers are intended to be used in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroentermology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculaplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: The FriendlyLight® Nd: YAG Laser systems are intended for the coagulation and hemostasis of henign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutancous lesions, such as warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lessons that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The FriendlyLight® Nd: YAG lasers are also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles. The FriendlyLight® Nd: YAG lasers are also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The FriendlyLight® Nd:YAG lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The FriendlyLight® Nd: YAG lasers are indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin. Surgical Application: The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT) neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/ thoracic surgery, gynecology (e.g. menorrhagia) and urology.
    Device Description
    The FriendlyLight® Nd:YAG Laser consists of a power supply unit, an air-cooling system, a foot Switch, and the hard prove are, the hand piece is held against the treatment area and the light an unfollow cord. In bather the foot switch and/or hand switch is depressed. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
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    K Number
    K013021
    Device Name
    LIGHTLANCE LASER SKIN PERFORATOR
    Manufacturer
    INNOTECH USA, INC.
    Date Cleared
    2002-05-30

    (265 days)

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

    INNOTECH USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LightLance™ Laser Skin Perforator is intended to be used for ablation of skin tissue to establish capillary blood access. The LightLance™ Laser Skin Perforator general indication for use is for the perforation of skin to draw capillary blood for screening purposes. The device is specifically indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration in both institutional and home settings.
    Device Description
    The LightLance™ Laser Skin Perforator is a pulsed erbium doped yittrium-aluminumgamet (Er: YAG) laser. It outputs a single pulse of laser light with a wavelength of 2940 nm, which ablates a small hole in the skin to a depth sufficient to access capillary blood.
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    K Number
    K000023
    Device Name
    FRIENDLY LIGHT ER:YAG PULSED LASER
    Manufacturer
    INNOTECH USA, INC.
    Date Cleared
    2000-11-06

    (307 days)

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

    INNOTECH USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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