InbellaIgnite RF System

The InbellaIgnite RF System is a radiofrequency device for dermatological and general surgical procedures requiring soft tissue coagulation, contraction, or hemostasis. It consists of a console with power supply, RF generator, and controller connected to multiple handpiece types (monopolar RFAL, bipolar BellaQ, and fractional BellaM8) that deliver RF energy to tissue. At higher energy levels greater than 62 mJ/pin, BellaM8 use is limited to Skin Types I-IV.

The system design and components—including console, handpieces, cable, connector, handle, and RF energy-delivering electrodes—are similar to the predicate InMode RF systems. Safety features and compliance with safety standards match the predicate. Patient contact materials are identical. The main modification is the addition of a new Burst mode operation for BellaM8 handpieces, which was validated through software testing. No new biocompatibility testing was required since patient contact materials are unchanged.

Not stated in this summary.

The InbellaIgnite System is substantially equivalent to predicate devices (InMode RF system K240780 and InMode System with Morpheus8 Applicators K231790) because it has identical indications for use and substantially equivalent technological characteristics. Although it adds a Burst mode, the company conducted comparative ex vivo thermal safety testing and a multi-site split-body clinical study demonstrating equivalent treatment effects, coagulation patterns, and safety outcomes between Burst and previously cleared Cycle modes. Software and cybersecurity validation per FDA guidance was also completed, confirming no new safety or effectiveness concerns.