Dectro International

Dectro International specializes in three main categories of devices: single-use needle electrodes for electrolysis hair removal, professional electrolysis systems designed for permanent hair reduction, and multi-modality skin surface treatment systems. These systems combine techniques like radiofrequency and light therapy to address skin rejuvenation at a superficial level. The company’s focus spans both hair removal solutions and cosmetic skin treatments.

Dectro International is based in the United States. Since the company operates within the US, its devices are subject to FDA regulations, including classification under FDA’s device categories and potential listing in the FDA’s Unique Device Identifier (UDI) database. This ensures compliance with US medical device standards and requirements.

Dectro International’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and market surveillance purposes. This listing is relevant for devices classified under FDA’s Class I and Class II categories.

Dectro International’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body’s interaction with it, such as the precision of needle electrodes or the energy output of skin treatment systems.