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FDA cleared for the best treatments!

Our devices are FDA cleared by the Food and Drug Administration. In this way we give you certainty of safety and we ensure the best results!

FDA goedgekeurde apparaten

What is the FDA?

De Food and Drug Administration (FDA) is het agentschap van de federale overheid van de Verenigde Staten (VS) en is verantwoordelijk voor de bescherming van de volksgezondheid. Dit doen ze door de kwaliteit van voedsel en medicijnen te controleren.

FDA assessed the safety and efficacy of:

  • Products that emit radiation (e.g. X-rays, microwaves)
  • Surgical Implants
  • Medical devices (everything from wooden tongue depressors to pacemakers)
  • Prescription drugs for humans and animals
  • Over-the-counter medications
  • Biological medicines (e.g. vaccines, blood products, biotechnology products and gene therapy)
  • Dietary supplements (not all are subject to FDA regulation)
  • Food supplements
  • Tobacco products
  • Infant formula

What makes an FDA approval so special?

A product is only FDA approved if the effectiveness and safety of the product is good. There is a whole research behind it in which a lot of time and money is invested.

This quality mark is much stricter than the CE mark that we use in Europe. Products with FDA approval are therefore much more reliable. If the FDA grants an approval, this means that it has been determined that the product has no risks or that the benefits of the product outweigh the known risks (for example, drug use).

Our FDA-cleared devices

Interested? Schedule a free consultation

Are you interested in the possibilities we have for your skin? Plan a free consultation and discuss the options with a specialist.


Thermage FLX & Fraxel Laser

Academy, Behandelingen & International Back Office
Rozengracht 215
1016 LZ Amsterdam
+31 20 79 20 792

Thermage FLX & Fraxel Laser

Opernplatz 14
60313 Frankfurt am Main
+49 69 20 43 60 88

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