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Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. Fractional mode is indicated for only ablative skin resurfacing

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This document (K230268) is an FDA 510(k) clearance letter for the ZenPro 40 device, a laser surgical instrument. It outlines the device's indications for use and confirms its substantial equivalence to predicate devices. However, this letter does not contain any information regarding acceptance criteria or the study that proves the device meets acceptance criteria.

The information requested in your prompt typically comes from the technical documentation or a clinical study report submitted to the FDA as part of the 510(k) application, which is not included in this clearance letter.

Therefore, I cannot provide the details you've asked for based on the provided text. To answer your questions, one would need access to the actual submission or summaries of the performance data that were part of the 510(k) application for the ZenPro 40.

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