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The iClear Phototherapy System is intended to provide phototherapeutic light to the body. The iClear is generally indicated to treat dermatological conditions. The iClear is specifically indicated to treat moderate inflammatory acne vulgaris.

The iClear Therapy System is a high intensity lamp intended for the therapy of dermatological disorders such as moderate inflammatory acne vulgaris by emitting visible light in the violet-blue range with fluency of light ranging between 50-200 mW/cm². The system includes a spectral band light source with spectral emittance concentrated in the violet/blue spectral band and an optical system for controlling spectra and beam parameters of the light source. It also includes a mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area, and an timer unit to indicate the duration of light treatment.

I am sorry, but the provided text is a 510(k) summary and not a study report. The document describes a medical device seeking clearance (iClear Phototherapy System) and states its substantial equivalence to a predicate device (CureLight ClearLight).

However, it does not contain any information regarding clinical studies, acceptance criteria, or performance data for the iClear device. Therefore, I cannot extract the requested information such as a table of acceptance criteria and reported performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

The document focuses on the device's intended use and technological characteristics to demonstrate its similarity to an already cleared product, rather than providing evidence of its own clinical effectiveness through performance metrics.

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