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NaturaLight IPL System (intense pulsed light) is indicated for: The removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. The treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait. treatment of vascular lesions, including port wine stains, hemangiomas, telangiectasias, rosacea, facial and leg veins.

The Focus Medical NaturaLase LP Laser System and the NaturaLase LP+ System when used in Laser Mode is indicated for: General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue dermatology/plastic surgery, endoscopic/laparoscopic general surgerv. in 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 - VI) including tanned skin.

Endoscopic/Laparoscopic Surgery: The Natural.ase 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, 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 turnors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids.

Gynecology: Treatment of menorhagia 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 biopsv 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, granilo mas, 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).

The Focus Medical NaturaLase LP and NaturaLight Family of Products consists of the NaturaLase LP Nd: YAG Laser System, the NaturaLight IPL System and the NaturaLase LP+ a simple combination of the NaturaLase LP and the NaturaLight.

This document is a 510(k) premarket notification for a medical device submitted to the FDA in 2004. It outlines the device's summary and indications for use, but does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to predicate devices, not on performance studies with specific acceptance criteria.

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