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The Clear100™ Phototherapy System (" Clear100™ ") is intended to provide phototherapeutic light to the body. The Clear100 ™ is indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris and infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

The Clear100™ Therapy System is a high intensity lamp emitting visible light in the violet-blue range (405 nm to 420 nm) and in the near infrared range (850-890nm) with a 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 near infrared range with 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 a timer unit to indicate the duration of light treatment.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria.

The 510(k) submission for the CureLight Clear100 Phototherapy System focuses on demonstrating substantial equivalence to a predicate device (CureLight ReClear). It primarily describes:

• Intended Use: What the Clear100 is designed to do (provide phototherapeutic light for moderate inflammatory acne vulgaris and infrared light energy for temporary relief of aches, pains, stiffness, and muscle relaxation).
• Technological Characteristics: Specifications of the device (light wavelengths, fluency, components like light source, optical system, mechanical fixture, and timer).
• Substantial Equivalence Argument: An assertion that due to similar intended use, indications, and technological characteristics (with minor differences not raising new safety/effectiveness questions), the Clear100 is substantially equivalent to the ReClear.

There is no mention of:

• Specific performance acceptance criteria (e.g., a certain percentage reduction in acne lesions or pain scores).
• A clinical study or any study data showing the device's performance against such criteria.
• Sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any study.
• MRMC studies or standalone algorithm performance.

The FDA's letter (K041569) confirms that the device has been found substantially equivalent based on the provided information, allowing it to be marketed, but does not detail a performance study.

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