# K251435: InbellaIgnite RF System

- Pathway: 510(k) (Traditional)
- Applicant: Inbella Medical, Inc.
- Decided: Jan 27, 2026 after 264 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: 24 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)
- K240780: InMode RF System, InMode, Ltd. (2024) Summary page 5.
- K231790: The InMode System with the Morpheus8 Applicators, InMode, Ltd. (2023) Summary page 5.

## Indications for use
The Inbellalgnite System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed. BellaM8: At higher energy levels greater than 62 mJ/pin, the use of the BellaM8 Burst and Burst Deep Applicator is limited to Skin Types I-IV.

Source page: https://510kreport.com/device/K251435
Methodology: https://510kreport.com/methodology