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Scanning Device Accessory for use with the CB Erbium / 2.94TM Er:YAG Laser for general dermatology (soft tissue ablation) and skin resurfacing in the treatment of wrinkles.

The Scanning Device Accessory is a microprocessor controlled device that generates precisely defined repeatable patterns in an automated sequence to increase treatment speed and facilitate uniform ablation of tissue.

The provided document, K971879, is a 510(k) summary for a "Scanning Device Accessory for the CB Erbium / 2.94TM Er:YAG Laser." This document states that no nonclinical or clinical performance data was provided or reviewed for this submission. Therefore, there is no information available to describe acceptance criteria or a study proving the device meets those criteria.

The submission concluded that the device "enhances the clinical application procedure while maintaining the performance characteristics" but this was based on comparison to an equivalent device (SoftScanTM Scanning Device, Sahar Technologies, Inc. K964684) and not on new performance data for the K971879 device itself.

Given the absence of performance data, all sections of your request regarding acceptance criteria and performance studies cannot be answered from this document.

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