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The Cheveux Diode Laser System is indicated for:

• Hair Removal
• Permanent hair reduction
• Treatment of benign vascular lesions
• . Treatment of benign pigmented lesions
• Treatment of Leg Veins
• . Treatment for pseudofolliculitis barbae

The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin.

The 810nm Diode Laser System consists of a console that houses the power supply, control electronics and user interface and a diode laser handpiece. The device is activated by means of a footswitch and a handswitch.

The Laser System is designed for use in a clinic, which shall be a clean, dry and wellventilated room with a door.

The provided text is a 510(k) summary for a medical device called "810nm Diode Laser System." It details the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets performance claims through clinical studies or AI algorithm performance. The "tests" mentioned are non-clinical and relate to electrical safety, EMC, and radiation safety, which are regulatory compliance tests, not performance studies as would be conducted for an AI/ML device or a device requiring clinical evidence.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them, as this information is not present in the provided text. The document explicitly states:

• "The 810nm Diode Laser System has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device."
• "The tests include the concerning of electrical safety, EMC and the requirements of radiation safety, test data and report information are included in this submission. IEC 60601-1, EN 60601-1-2 : 2015 (EN 55011: 2009+ A1: 2010), EN 60601-1-2 : 2015, EN 61000-3-3, EN 61000-3-2."

These are standards for basic safety and essential performance, not clinical performance or efficacy studies. The substantial equivalence is based on similar technological characteristics and non-clinical safety/EMC standards, not on a study proving specific performance metrics like those for an AI/ML device (e.g., sensitivity, specificity, or improvement in human reader performance).

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