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What does a Medical CE mean?

The security of E-One, flash lamp hair removal device for a so called permanent hair removal

Any device that is available for purchase in Europe bears a CE logo, this logo is verification that the product is safe to use. However, it is unfortunately common to find many companies affixing a CE logo on their own accord to the product without any safety tests.

In Europe, when it comes to devices that are designed to interact with the body, a different kind of CE is required: a Medical CE.

The approval process for a Medical CE includes an extra set of rules compared to a normal CE mark. These extra rules are designed offer the end user an assurance that the product they are using (providing it is used within the recommended guidelines) is completely safe.

The Medical CE can only be issued by approved authorities; these authorities are worldwide and are independent, accredited organizations (ie. SGS and Veritas). Due to this separation of duties, the manufacturer cannot have any influence upon the Medical CE application process.

The E-One hair removal device is 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 9001 and ISO 13485.

Safety Standards

The E-One hair removal device was designed with a total of 12 levels of security, most of which were patented.

This implementation allows a safe usage of the device in the comfort of your home.

An obsession with quality

In the current production climate, the making of a good quality product requires a manufacturing company to adhere to ISO 9001 and ISO 13485 standards. The implementation of these strict rules enable a level of traceability for the E-One’s components and for each 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, but we would rather provide a guarantee of the utmost in terms of quality.

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- Electronic hair removing at home - At home just like beauty salons - permanent hair removal cheaper than laser -