The manufacturing processes of MedLaser Family Ltd. are conducted in the framework of the ISO 13485 medical quality assurance standard, which guarantees a consistent and fully controlled manufacturing quality as well as the rapid and controlled elimination of any possible defect.
The devices manufactured by MedLaser Family Ltd. comply with the requirements specified in Council Directive 93/42/EEC concerning medical devices (the Medical Devices Directive).
Within the EU, medical devices cannot be marketed without the CE mark, as this mark indicates that the devices conform to the requirements specified in Council Directive 93/42/EEC concerning medical devices and can be freely marketed on the internal market of the European Economic Area (EEA). The annual accreditation of our company’s activities and products is done by EMKI-OGYÉI of code number 1011 [Medical Device Qualification and Hospital Engineering Directorate or the National Institute of Pharmacy and Nutrition], which is a notified body authorized for this task.
We put large emphasis on quality, thus every single device created is tested by an expert supervisor. MedLaser is manufacturing white-label products for Swiss and Japanese companies.
‘Dentists need lasers of multiple different wavelengths so that they can offer comprehensive laser treatments for their patients. The teeth, the joints, the mucous membranes and surgical interventions all require a laser of different wavelength.
The fact that all these different wavelengths are provided by the same device makes the treatments much easier and considerably shortens the treatment times.
For dental clinics with a high patient turnover it is a must to have a combined laser.’Dr. Ida Kútvölgyi, Dental Specialist
‘I have been using the device developed by MedLaser Family for nearly six months. My interest was caught primarily by the advanced features offered by the device and secondly by its favourable price/value ratio. It is my firm belief that in this second aspect the device is ‘unbeatable’ on the market.
The device offers all the features that may be needed in an average dental practice. I personally find it very useful in paediatric dentistry (e.g. for frenulectomy in a child- and parent-friendly manner).
I also use it for dental surgery interventions and also for supporting the healing process… and all these uses are offered by a single device!
The patients’ feedback is definitely positive.
The device is easy to use, its design is practical. It is good to work with!’Dr. Anita Fáber, Dental Specialist, Paediatric Dentist