FDA OKs follicle-harvesting device

April 27, 2011

The Food and Drug Administration has granted 510(k) clearance to the ARTAS System, a device for harvesting hair follicles from the scalps of men with straight black or brown hair who have been diagnosed with androgenetic alopecia, Medical News Today reports.

Mountain View, Calif. - The Food and Drug Administration has granted 510(k) clearance to the ARTAS System, a device for harvesting hair follicles from the scalps of men with straight black or brown hair who have been diagnosed with androgenetic alopecia, Medical News Today reports.

ARTAS, developed and marketed by Restoration Robotics, based here, is a computer-assisted system for harvesting follicles during hair restoration procedures. Its features include an image-guided robotic arm, special imaging technologies, small dermal punches and a computer interface.

According to the company, the ARTAS System can identify and harvest individual follicular units to implement the follicular unit extraction (FUE) technique.