Quality & Safety Concerns

 

LEIMO ensures its services and products are of the highest quality and have received appropriate safety certifications.

 

The LEIMO Personal Hair Laser received the world's first EC Certificate for promotion of hair growth issued in compliance with the Council Directive 93/42/EEC which certifies medical devices of Class IIa. This ensures the LEIMO Personal Hair Laser conforms with all the health and safety requirements set out in European Directives.

 

The Australian community expects that medicines and medical devices in the marketplace are of a standard at least equal to that of comparable countries. There is a national framework for the regulation and registration of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and ensure the quality, safety and performance of medical devices. The LEIMO Personal Hair Laser is included on the Australian Register of Therapeutic Goods as a Class IIa medical device with the intended purpose of treating people with mild to moderate Androgenic or Androgenetic Alopecia (Male or Female pattern baldness). Leimo is not suitable for severe Androgenic or Androgenetic Alopecia or other forms of hair loss such as Alopecia Areata, Telogen Effluvium and Cicatricial Alopecia.