Regulatory Status of YOLO MEDICAL Inc. Lapex BCS, Lucia & YOLO Curve:
The Lapex 2000 510(k) (k034009), Lapex BCS 510(k)(k081962), Lucia 510(k)(k102375) and YOLO Curve 510(k)(k110324) are cleared by USFDA with indication intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

According to FDA guidelines, devices can only be promoted, advertised and marketed for the indication that they are approved for.

For additional information, contact the FDA directly at: 1.888.463.6332 or visit them online at www.fda.gov.

Yolo Medical Inc.

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