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The ACMI® DUR-HL Laser Systems are intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (for example, strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (for example, DCR), Lithotripsy, Orthopedics, Discectorny and General Surgery.

The ACMI® DUR-HL Laser Systems are pulsed solid-state Holmium YAG Lasers with a wavelength of approximately 2080 nm (2.1um). This wavelength is absorbed primarily by water, whereby an average penetration depth of approx. 400 um (0.4 mm). The lasers are Class IV lasers pursuant to 21CFR 1040 and designed to comply with the requirements outlined in 21 CFR 1040. The ACMI® DUR-HL Laser Systems are comprised of the following components:

• Laser Unit, which includes Laser console, control and display panel .
• . Fiber port for delivery systems
• System microprocessor control electronics .
• Covered footswitch .
• . Operating software
• (For use with) a variety of fiber optic delivery devices/accessories. .

Acceptance criteria and device performance information is not present in the provided text. The text describes a 510(k) submission for a laser surgical instrument, focusing on its intended use, technological characteristics, and substantial equivalence to predicate devices, but lacks details on specific performance metrics or clinical study results.

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