Safety

• TGA Certification
• International Certification
• Medial CE Certification
• Safety Standards
• An Obsession with quality – ISO 9001 and 13485

TGA Certification

Inclusion in the Australian Register of Therpeutic Goods. France Cosmetic is proud to announce that The E-One is included in the Australian Register of Therpeutic Goods for treatment of Hirsutism. (excessive hair growth)
ARTG Number #167727.

international certification

Medical CE - 93/42/ECC
ISO 9001 – 2000
ISO 13485 – 2003

medical certification

In Europe, medical devices require CE certification. Comprehensive documentation to demonstrate the safety and efficacy of the device is required to obtain medical CE certification.

A Medical CE can only be issued by approved authorities; these authorities are worldwide, independent, accredited organizations (ie. SGS and Veritas). 

The E-One hair removal device is, as far as we are aware, the only home-use IPL device in the world to possess a Medical CE mark. The device was able to pass the stringent requirements of a Medical CE due to the high standards adhered to by the manufacturing company. The standards adhered to include ISO 13485 and electrical safety tests.

SAFETY STANDARDS

The E-One hair removal device was designed with a total of 12 stages of safety, meaning users have to confirm they are using the device safely.

AN OBSESSION WITH QUALITY – ISO 9001 AND 13485

For a company to produce a high quality product, they are required to adhere to the ISO 9001 and ISO 13485 standards. The implementation of these strict rules provides a level of traceability for both the E-One’s individual components and every E-One device sold. A high level of quality control is implemented on every component of the E-One device throughout the manufacturing process, which is followed by an array of stringent tests.

The implementation of these rules does have an impact on the sale price, as France Cosmetic would rather provide a guarantee of the utmost in terms of quality.