How HIFU works
High-intensity focused ultrasound concentrates energy at a defined depth below the skin surface. Small thermal points form there while the surface stays intact. Typical depths are 1.5 and 3 mm for the skin, 4.5 mm for the deeper connective layer of the face and 6 to 13 mm on the body.
Cartridges, shots and refills
Check which depths are available as cartridges, how many shots a cartridge holds and how easy it is to change. A system with face and body cartridges covers more applications. Also clarify reordering and delivery times for cartridges.
Who may use HIFU in Germany?
Under section 9 NiSV, ultrasound that deliberately coagulates tissue thermally or reduces fat is reserved for physicians. HIFU falls into this group, so in Germany the device is aimed at physician-led clinics. For beauty studios, cold radiofrequency is often the better choice for firmer-looking skin.
Checklist before you buy
- Is a physician involved in the treatments?
- Which cartridge depths for face and body are included?
- How many shots per cartridge, how does reordering work?
- Are training and treatment protocols included?
- Has operation been notified to the authority?
Frequently asked questions
May a beautician use HIFU in Germany?
No. HIFU aims at thermal coagulation in tissue and is reserved for physicians under section 9 NiSV.
What is an alternative to HIFU for beauty studios?
For firmer-looking skin many studios use cold radiofrequency such as 20 MHz Cold CRF. The NiSV applies here too, with notification and certified expertise.
Which cartridges does the 360 Ultra HIFU have?
The system works with cartridges from 1.5 to 13 mm depth for face and body. We discuss the exact configuration in a consultation.
Sources
- Bundesumweltministerium: Grundsätzliche Fragen zur NiSV
- NiSV, Verordnungstext (gesetze-im-internet.de)
This guide is for orientation only and is not legal advice. The current text of the regulation applies. If in doubt, please ask the competent authority.