MEDICAL DEVICE


MEDICAL DEVICE

The O2-BALANCE has been developed on the results of the latest researches. It enables to carry out innovative treatments and extremely deep active substance intake. It can be used in medical surgeries, aesthetical institutions and exclusive beauty salons with the highest possible security. Damage cannot be caused with the device, and its treatments can be understood and learnt easily. 

This rating is a guarantee for the outstanding efficiency and the 100% security of the treatments. The device cannot damage the skin and the treatments are pain-free.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).