# K252215: InbellaMAX System

- Pathway: 510(k) (Special)
- Applicant: Inbella Medical, Ltd.
- Decided: Jul 25, 2025 after 10 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: 25 generations back to K943450 (1995). 646 ancestors in all.
No later device cites it as a predicate yet.
0 of 647 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251632: Optimas MAX System, InMode, Ltd. (2025) Summary page 5.

## Indications for use
The InbellaMAX System with the BellaXL 810 Black is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The BellaXL 755/810 Black and the BellaXL 810/1064 Black are intended for hair removal. The InbellaMAX System with the BellaVlaze Black is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The InbellaMAX System with the Bella515 and Bella580 Black Applicators are indicated for use for the following treatments: • The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); • The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncaland leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations. The InbellaMAX System with the BellaPlus and BellaForma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The InbellaMAX System with the BellaM8 BApplicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

Source page: https://510kreport.com/device/K252215
Methodology: https://510kreport.com/methodology