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Disclaimer: Light Therapy International does not warrant any claims of healing provided by these European medical studies. It should be noted that although the BIOPTRON devices have obtained FDA clearance based on 510 (k) submission (K032216) as per following Rx indication of use: The BIOPTRON Light Therapy Systems is indicated for use in providing relief of minor chronic neck and shoulder pain of muscular-skeletal origin'. However, currently BIOPTRON devices are not imported in USA as per medical devices but only cosmetic device.