Venus Concept NeoGraft 2.0

NeoGraft is an automated follicular unit extraction system used to harvest hair grafts and implant them, without removing a strip of scalp. Venus Concept acquired the NeoGraft business in 2018, according to its annual report for 2019. The FDA device database lists a Neograft device with version 2.0, published in December 2018, under the labeler Electronique du Mazet, and Venus Concept's annual reports list a production site in Mazet, France. Venus Concept treats NeoGraft as a class I device that is exempt from 510(k) clearance.

Venus Concept's current product page describes the system's main parts. A pneumatic, piston driven motor provides pressure control for both extraction and implantation, and what the company calls Smart Drive Torque drives the contra angle and punch. The contra angle head turns at up to 3000 rpm and seals with vacuum to protect grafts, and the console reaches a maximum vacuum of minus 800 mbar. A separate handpiece creates recipient sites, and a no touch implanter places grafts at a pressure of up to 2.5 bars. The handpieces are autoclavable. The touchscreen switches between extraction and implantation modes, counts grafts in real time and includes user management tools.

NeoGraft is a handheld, operator guided system, not a robot, which separates it from the ARTAS line that Venus Concept also sells. The company describes NeoGraft as usable for women and for patients with curly or light colored hair, groups outside the ARTAS clearance. To confirm a 2.0 unit, read the version on the device label, and note whether it has the double jointed arm shown in current Venus Concept material.

Handpieces do the work, so buyers ask about each one: how many contra angles, site making handpieces and implanters come with the system, and whether they have been autoclaved and stored properly. Include the service history. Photos of the device label, the touchscreen, the arm and the full set of handpieces help a dealer confirm the version and judge its condition.