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The CO2 Laser Therapy Systems is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.

CO2 Laser Therapy Systems is monochromatic light with strong penetration and precise focusing; When a continuous laser beam with a certain energy irradiates biological tissue, the instantaneous high temperature causes photo induced solidification and photo induced vaporization to irradiated tissue.iradiates biological tissue, the instantane causes photo induced solidification and photo induced vaporization to irradiaed tissue. With modulation pulse mode of CO2 laser, treatment effect can be achieved by control of laser emission frequency. After chosing laser Power, despite the frequency of laser emission, the laser is continuously output at a fixed Interval Time of 1 ms. Changes in frect interval time.

This document is a 510(k) premarket notification for a CO2 Laser Therapy System (SHE-LSP003-1). It does not describe an AI/ML powered medical device, therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies for an AI device is not available in the provided text.

The document focuses on demonstrating substantial equivalence to predicate devices (K161925 and K241670) based on technological characteristics and performance standards for laser therapy systems, not AI performance. It explicitly states, "No clinical study is included in this submission."

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