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510(k) Data Aggregation

    K Number
    K031828
    Device Name
    NATURALASE LP ND:YAG LASER
    Manufacturer
    FOCUS MEDICAL, LLC.
    Date Cleared
    2003-07-17

    (34 days)

    Product Code
    GEN, GEX
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Focus Medical NaturaLase LP Laser is indicated for: General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology. Dermatology/Plastic Surgery: Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins. In addition, the NaturaLase LP is 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, seborrheic keratoses, nevi chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The NaturaLase LP Laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery. The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles. The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The NaturaLase LP Laser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The NaturaLase LP Laser is indicated for use on all skin types (Fitzpatrick I - IV) including tanned skin. Endoscopic/Laparoscopic Surgery: The NaturaLase LP Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied. Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestinal hemostasis including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, gastrointestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, and hemorrhoids. General Surgery: Incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids. Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum. Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis. Hemostasis During Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures. Neurosurgery: Hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma. Oculoplastics: Incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents. Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications. Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures. Thoracic Surgery: Cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy). Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).
    Device Description
    The Focus Medical NaturaLase LP Laser in a long-pulse Nd: YAG Laser operating at 1064 nm.
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