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The Evis MD Platinum Red Light Therapy device is intended to provide light to the body. Generally indicated to dermatology use for the treatment of superficial, benign vascular and pigmented lesions "such as but not limited to solar lentigines, sun spots, liver spots and age spots".

The Evis MD Platinum Red Light Therapy device that utilizes Light Emitting Diodes to provide LED light to the body. The hand held device contains the power supplies and a built in audible indicator with auto shut off. The device delivers the light to the skin as it moves over the skin. The wavelength for red is 630 +/- 5 nanometer. Evis MD Platinum Red does not use any software.

The provided text pertains to a 510(k) premarket notification for a medical device called "Evis MD Platinum Red Light Therapy." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through clinical studies of its efficacy for its stated indications.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as such a study is not typically required for a 510(k) submission for this type of device. The provided text primarily focuses on:

• Device Description and Intended Use: The Evis MD Platinum Red Light Therapy device uses LEDs to deliver red light (630 +/- 5 nm) for dermatology use, specifically for superficial, benign vascular and pigmented lesions.
• Predicate Device: It claims substantial equivalence to the Omnilux Revive (K030426).
• Nonclinical Performance Data: The device was tested for electrical safety (IEC/EN/UL 60601-1) and electromagnetic compatibility (IEC/EN 60601-1-2, FCC 47CRF PT 18, ICES 005). This demonstrates safety and compliance with standards, not clinical efficacy or acceptance criteria related to its therapeutic claims.
• Conclusion: The manufacturer concludes that no significant differences exist between their device and the predicate, and it does not pose new safety or effectiveness concerns.

In summary, none of the requested information (table of acceptance criteria, study details, sample sizes, expert qualifications, ground truth methods, or comparative effectiveness) can be extracted from this 510(k) summary, as it describes a regulatory submission focused on substantial equivalence based on technological characteristics and safety standards, rather than a clinical trial demonstrating efficacy against pre-defined acceptance criteria for its intended therapeutic use.

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