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EAR, NOSE AND THROAT AND ORAL SURGERY: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity.
ARTHROSCOPY: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery.
GASTROENTEROLOGY: Hemostasis, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy.
GENERAL SURGERY, DERMATOLOGY & PLASTIC SURGERY, AND PODIATRY: excision, ablation, and vaporization of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissues, and dermabrasion.
GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues.
GYNECOLOGY: ablation, excision, hemostasis and vaporization of tissue.
NEUROSURGERY: Hemostasis.
OPHTHALMOLOGY: Incision, excision and vaporization of tissue surrounding the eye and orbit; Photocoagulation of the retina.
PULMONARY SURGERY: Hemostasis, vaporization, and excision of tissue.
UROLOGY: Hemostasis, vaporization and excision of tissues.

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This document is a 510(k) clearance letter for the Aurora™ SL Diode Laser System, indicating that the device is substantially equivalent to previously marketed devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The content primarily focuses on the regulatory aspects of the device, including:

• Trade Name: Aurora™ SL Diode Laser System
• Regulatory Class: II
• Product Code: GEX
• Manufacturer: Premier Laser Systems, Inc.
• Clearance Date: November 18, 1999
• Indications for Use: A comprehensive list across various medical specialties (ENT & Oral Surgery, Arthroscopy, Gastroenterology, General Surgery, Dermatology & Plastic Surgery, Podiatry, GI/GU, Gynecology, Neurosurgery, Ophthalmology, Pulmonary Surgery, Urology).

Since the provided text is a 510(k) clearance letter and not a clinical study report or a summary of performance data, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, or MRMC studies. Such details are typically found in the technical documentation submitted with the 510(k) application, but they are not present in this clearance letter itself.

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