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WAW WIRELESS HANDPIECE

Devroye Instruments Belgium · Model 2 · UDI-DI 05430003362006

GEY Prescription

510(k) clearances

18,194

Adverse events

Recalls

147

Facilities

Description

The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. This is done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respect to naturalness and density) and the donor (taking care of the donor region). The WAW Duo FUE System is composed of the following: - The WAW Wireless Handpiece: o Composed of a motor and a battery, and a detachable cleanable (via autoclave) external sleeve o Connected via Bluetooth to the tablet o Responsible for the rotation and oscillation movements of the punch (not included) for the FUE, - The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece: o Cleanable (via autoclave) o Connected via a wire to the pedal o Responsible for the rotation and oscillation movements of the punch for the FUE, - The WAW Pedal, responsible for activating the handpieces, - The WAW Software, responsible for defining the parameters of functioning (rotation and oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the pedal (the Samsung tablet is supplied), - The WAW Charging Station, intended to recharge the wireless handpiece and - The External Sleeve Support Box, intended to sustain external parts of WAW Wireless Handpiece and WAW Wired Handpiece during autoclave process. - Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.

Recalls

Date	Firm	Reason
2023-02-15	Pro-Dex Inc	Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch
2018-09-25	Pro-Dex Inc	Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
2017-03-28	Aesculap Implant Systems LLC	Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m
2017-03-28	Aesculap Implant Systems LLC	Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m
2017-03-28	Aesculap Implant Systems LLC	Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.