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The Excilite and Excilite μ phototherapy systems are indicated for the treatment of leukoderma, psoriasis, vitiligo, eczema, and seborrheic dermatitis, for skin types I to VI.

Excilite and Excilite-μ phototherapy systems have a XeCl excimer gas lamp located in the handpiece. It is a light source with a range approximately 306 - 310 nm wavelength. Emission activation is by finger switch. Overall weight of the laser is 19 Kg, and the size is 50x38x24 cm (HxWxD). Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The provided text is a 510(k) summary and an FDA clearance letter for the Excilite and Excilite μ phototherapy systems. These documents primarily focus on demonstrating substantial equivalence to a predicate device for market clearance, rather than presenting a performance study with acceptance criteria.

Specifically:

• The "Nonclinical Performance Data" and "Clinical Performance Data" sections in the 510(k) summary both state "none." This indicates that no specific performance studies (clinical or non-clinical) were submitted or summarized for this device to establish new acceptance criteria.
• The FDA letter confirms that the device was cleared based on its substantial equivalence to a legally marketed predicate device, not on meeting new performance criteria from an independent study.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

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