Renuva

Device Name

Medical Non-ablative Fractional Laser Systems

Model / Reference

WFA-01

Primary DI / UDI-DI

06972978060109

Basic UDI-DI

B-06972978060109

EMDN Code

X0501,Z12011014

Device Class

Class IIb

Market of Registration

Germany

EUDAMED SRN

CN-MF-000007136

Authorised representative

Prolinx GmbH DE-AR-000005129

• Non-ablative Fractional Laser Systems

  Class IIb

  CE/MDR

• Lasermach Diode Laser Hair Removal Device

  Class IIa

  CE/MDR

• Medical Non-Ablative Fractional Laser Systems Open recall

  Class II

  CE/MDR FDA 510(k) K192350 Active Cleared 30 Apr 2020

• Diode Laser Therapy Systems Open recall

  Class II

  FDA 510(k) K191611 Active Cleared 31 Jul 2019

• Diode Laser Therapy Systems (WLA-02)

  Class II

  FDA 510(k) K252599 Active Cleared 24 Feb 2026

• Lasermach Diode Laser Hair Removal Device

  Class IIa

  CE/MDR

See all devices from Wingderm Electro-Optics Ltd. →