# K252367: InbellaMulti System

- Pathway: 510(k) (Traditional)
- Applicant: Inbella Medical, Inc.
- Decided: Oct 15, 2025 after 77 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 265 ancestors in all.
No later device cites it as a predicate yet.
0 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210492: InMode RF Pro System, Inmode MD, Ltd. (2021) Summary page 5.
- K231790: The InMode System with the Morpheus8 Applicators, InMode, Ltd. (2023) Summary page 5.

## Indications for use
The InbellaMulti System with the Non-invasive Applicators employs RF energy for various applications: * i-BellaForma, BellaForma, BellaPlus and BellaPlus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. *BellaWMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids. * BellaBodyF X /BellaMiniFX for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite. The InbellaMulti System with the Fractional Applicators employs RF energy for various applications: * BellaFractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. * BellaFractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-1V * BellaM8 for dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

Source page: https://510kreport.com/device/K252367
Methodology: https://510kreport.com/methodology