| K-number | K252367 |
| Device name | InbellaMulti System |
| Applicant | Inbella Medical, Inc. |
| Product code | GEI |
| Device class | Class II |
| Decision date | Oct 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
The InbellaMulti System is a radiofrequency (RF) electrosurgical device with multiple applicators for various medical and cosmetic applications. It is used for relief of minor muscle aches, pain, muscle spasm, improvement of blood circulation, treatment of facial wrinkles, reduction of cellulite appearance, skin ablation and resurfacing, and hemostasis in dermatologic and surgical procedures.
The InbellaMulti System consists of a platform console with AC/DC power supply, two applicator connectors, RF generator, RF measuring circuit, controller, footswitch, and touch screen interface. It supports multiple radiofrequency applicators (non-invasive and fractional types) with single-use tips. The technological characteristics are identical to the predicate devices except for the BellaM8 applicators, which match the Morpheus8 applicators from K231790.
The device complies with ANSI AAMI ES 60601-1:2005/(R)2012 and amendments (general safety and essential performance), IEC 60601-1-6 Edition 3.1 (usability), IEC 60601-1-2 Edition 4.0 (electromagnetic disturbances), and IEC 60601-2-2 Edition 6.0 (high frequency surgical equipment).
The InbellaMulti System is substantially equivalent to the InMode RF Pro System (K210492) for all applicators except BellaM8, and to the InMode System with Morpheus8 applicators (K231790) for the BellaM8 applicator. The indications for use and technological characteristics are identical to the predicates; the only differences are the manufacturer name and device/handpiece names.
View the full FDA submission: accessdata.fda.gov