| K-number | K252215 |
| Device name | InbellaMAX System |
| Applicant | Inbella Medical , Ltd. |
| Product code | GEI |
| Device class | Class II |
| Decision date | Jul 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
The InbellaMAX System is a computerized medical device that generates laser, IPL, and radiofrequency energies for various dermatological treatments. It is intended for hair removal, treatment of vascular lesions, pigmented lesions, muscle pain relief, and soft tissue coagulation, depending on which applicator is used.
The InbellaMAX System has identical technological characteristics to the predicate device. It features interchangeable applicators (BellaXL, BellaVlaze, Bella515/580, BellaPlus, BellaForma, and BellaM8), a water-cooling system with radiator, pump, and temperature sensors, and computer-controlled treatment parameter adjustment.
The device complies with IEC 60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012, IEC 60601-1-2:2020-09, IEC 60601-1-6:2020-07, IEC 60601-2-2:2017-03, IEC 60601-2-22:2019-11, IEC 60601-2-57:2011-01, and IEC 60825:2007-03.
Substantial equivalence is based on the InbellaMAX System being identical in all aspects to the predicate InMode OptimasMAX System (K251632), with only the manufacturer and 510(k) holder differing. The indications for use and technological characteristics are identical to the predicate device, and the device meets the same recognized safety and performance standards.
View the full FDA submission: accessdata.fda.gov