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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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The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The fractional scanner is only for the treatment of wrinkles and skin resurfacing.

The CO2 Diode Laser Therapy Systems mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin is the main target of the CO2 fractional laser, after absorbed the energy of the laser, the water will release heat, then be evaporated and gasified immediately, the cutaneous lesion will be eliminated instantly. By setting up the suitable energy and other parameters on skin tissue based on its specific thermal relaxation time, the healthy tissue can be prevented from being harmed.

This document describes the premarket notification (510(k)) for the CO2 Laser Therapy Systems (K162398). The submission focuses on demonstrating substantial equivalence to a predicate device (CO2 Laser Therapy Machine, K161925) rather than providing a study where the device meets specific performance acceptance criteria from a clinical trial.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted because such a study is not part of this 510(k) summary. Instead, the document provides non-clinical performance data (biocompatibility, electrical safety, EMC, and software verification/validation) to support safety and effectiveness and substantial equivalence.

Here's a breakdown of the information that can be extracted, and where the requested information is not available:

1. A table of acceptance criteria and the reported device performance

This document does not present a table of specific acceptance criteria (e.g., specific clinical performance metrics like sensitivity, specificity, accuracy, or a reduction in wrinkles of a certain percentage) that the device was evaluated against in a clinical study. Instead, the performance data provided are non-clinical performance tests demonstrating compliance with recognized standards.

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