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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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The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows:

1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red. Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

The Q-Switched Nd:YAG Laser Systems is based on the Q-Switched Nd: YAG (1064 nm) and frequency doubled KTP Nd: YAG (532nm) Laser Technology. There is one optical cavity containing the Nd: YAG Crystal. It is composed of laser module, articulated arm, laser power supply, cooling system and display and control system.

The Q-Switched Nd: YAG Laser Therapy Systems works based on laser selective photothermy and blasting mechanism of Q-switched laser. Energy form particular wavelength with accurate dose will act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanophore from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enters into lymph circulation system and finally be discharged out of body.

The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.

The provided document is a 510(k) summary for the Beijing Sincoheren Science And Technology Development Co.'s Q-Switched Nd:YAG Laser Therapy Systems. It aims to demonstrate substantial equivalence to a predicate device, not to establish new safety or effectiveness. Therefore, the document discusses performance data in the context of equivalence rather than proving acceptance criteria for a novel device.

The document does not describe specific acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, or accuracy) for a new clinical indication or a new type of device. Instead, it relies on demonstrating that the performance characteristics of the proposed device are comparable to or better than those of the predicate device, and that it complies with relevant safety standards.

Here's an analysis of the provided information based on your requested points, framed within the context of a 510(k) submission for substantial equivalence:

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

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly that the proposed device performs at least as well as, or is sufficiently similar to, the predicate device in terms of technical specifications and safety. The reported device performance is presented as a comparison table against the predicate device.

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