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It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The Jeisys EdgeOne CO2 Laser is comprised of the following major components:

1. The main console unit
2. Delivery handpieces (2 surgical and one fractional)
3. Footswitch.
4. Accessories

This document is a 510(k) premarket notification for the Jeisys EdgeOne CO2 Laser and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The document details the device's substantial equivalence to predicate devices based on:

• Indications for Use: The Jeisys EdgeOne CO2 Laser is indicated for incision, ablation, vaporization, and coagulation of body soft tissues in various medical specialties, and for ablative skin resurfacing with a scanning unit. Its indications are identical to the secondary predicate (K133895) and largely overlap with the primary predicate (K100590).
• Technical Characteristics: A table compares the Jeisys EdgeOne CO2 Laser's technical specifications (e.g., laser type, wavelength, output power, pulse duration, scan area, spot size, operational modes) to those of the predicate devices. The specifications are largely identical to the primary predicate and comparable to the secondary predicate.
• Safety and Effectiveness Information: The document states that the device's compliance with several IEC standards (IEC 60601-1, IEC 60601-2-22, IEC 60601-1-2) demonstrates its safety.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as none of that information is present in the provided text. The document focuses solely on establishing substantial equivalence to legally marketed predicate devices for a conventional medical device (a CO2 laser), not an AI/ML-driven one.

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