BRANDS
Ulthera, Inc.
Follow each brand to the devices and source documents collected here.
Role in the reviewed material
Documented role: Manufacturer. The linked regulatory or manufacturer material is filed under this company for the devices listed above.
About this collection
This collects the device records reviewed so far, not a complete product portfolio. Follow a device for its individual specifications and outstanding verification work.
Related articles
Ultherapy Depths Explained: 1.5, 3.0 and 4.5 mm and What the 8 mm Screen Shows
The FDA 510(k) summary for K180623 lists the energy of a single Ulthera pulse at under 2 joules. The same filing places the device in Class II under 21 CFR…
Sources reviewed
- FDA 510(k) K233996 — Ulthera System (UC-1 Control Unit PRIME) ↗Regulatory record · Accessed 2026-09-09
- FDA 510(k) Summary K233996 — Ulthera System Console Modifications ↗Regulatory record · Accessed 2026-09-09