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The NLite System is indicated for use in the specialties of Dermatology and Plastic Surgery, and in particular for the treatment of wrinkles.

The NLite System is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of wrinkles.

The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:

• Main laser console incorporating the laser resonator and external optics, high voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
• Flexible fibre optic delivery device and optical handpiece;
• Footswitch for pulsing control.

The provided text details a 510(k) submission for the ICN Photonics NLite System, specifically for an expansion of its claims to include the treatment of wrinkles. However, it does not contain the detailed acceptance criteria for a study, nor the reported device performance against such criteria. The document is primarily a regulatory submission for substantial equivalence.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with the provided input. The document mentions that "Clinical data has been provided to demonstrate that the NLite system is safe and effective for the described indications for use," and "The clinical data provided has demonstrated that the specific indications for use is met and the safety and efficacy of the system has been proved," but it does not include the details of this clinical data.

To answer your request, information on the specific study design, acceptance criteria, and detailed results would be needed.

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