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For use in cutting, vaporizing and coagulating soft tissue for clinical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open & endoscopic general surger y

Accu-Pulse is a DC excited gas-slab pulsed CO2 laser which produces 1-15 watts average power (see below for additional Surgical specifications).

The document provided is a 510(k) summary for the Accu-Pulse CO2 Surgical Laser System. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove device performance is not available in the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of acceptance criteria with corresponding device performance metrics from a study. Instead, it provides a "Table of Substantial Equivalence" which compares the Accu-Pulse to two predicate devices on various features. This table implicitly defines the acceptable range of performance as being comparable to the predicate devices.

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