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The MeDioStar NeXT laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology.

The MeDioStar NeXT laser system is intended for the treatment of vascular lesions.

The MeDioStar NeXT laser system is intended for hair removal, permanent hair reduction and the treatment of pigmented lesions.

The MeDioStar NeXT is a pulsed diode laser emitting a wavelength of 800 - 950 nm, that is operated with a handpiece in contact with the skin

This 510(k) submission for the Asclepion Laser Technologies GmbH MeDioStar NeXT does not include specific acceptance criteria or a study demonstrating that the device meets such criteria.

The submission states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

Instead, the device is deemed substantially equivalent to predicate devices (LightSheer Duet K053628 and MeDioStar XT K050900) based on similar principles of operation, parameters, and indications for use. The conclusion is that "The MeDioStar NeXT is another safe and effective device for the treatment of vascular lesions, for hair removal, permanent hair reduction and the treatment of pigmented lesions" primarily due to its similarity to already approved devices, rather than new performance data.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this information is explicitly stated as "None" in the provided document.

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