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This product is intended for dermatological use by physicians and healthcare professionals for the following:

• Removal of unwanted hair in all skin types (from 570- to 1200mm filter) .
• Treatment of vascular and benign pigmented lesions, cutaneous lessons including . warts, scars, striae and facial and leg veins (from 550 to 1200mm filter).
• Treatment of Acne (from 390 to 1200nm filter) .

The device is designed and manufactured to emit a high intensity pulsed light applied to the patient's skin. The light is emitted by a quick discharge of capacitors on a xenon flash lamp with a high energy. The lamp delivers a wavelength in the band of 390-1200nm. The three principal parts of this system are:

• The Principal Unit which contain all circuitry to control the device.
• The Handpiece contains circuitry to control the Lamp & Filter group.
• The Lamp & Filter group is a removable box that contains Xenon Flash Lamp and Filter mounted on to the handpiece.

The provided documents do not contain information about acceptance criteria, device performance, or any studies with sample sizes, expert ground truth, or adjudication methods.

The documents are primarily a 510(k) premarket notification summary and a clearance letter from the FDA for the EPI-C PLUS device. They describe the device, its intended use, and indicate that it has been found substantially equivalent to a predicate device.

Specifically, the information requested in the prompt, such as:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance study
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

is not present in the provided text. The FDA clearance is based on substantial equivalence to a predicate device, implying that the safety and effectiveness are considered comparable based on existing data or established principles, rather than new performance studies detailed in these specific documents.

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