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The Polaris Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include:

Dermatology and Plastic Surgery for

Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions Photothermolysis

Dentistry (soft tissue only), including sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and oral surgery; Ear Nose & Throat; Otorhinolaryngology; Neurosurgery (coagulation only);

Ophthalmology/Oculoplastic; Pulmonary/Thoracic Surgery; Gastroenterology; Urology; Gynecology; Orthopedics; Podiatry; and General Surgery.

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This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. These details would typically be found in the 510(k) summary or the full submission, which are separate documents from the clearance letter itself.

Therefore, I cannot provide the requested information based solely on the provided text.

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