Optimas MAX System

The Optimas MAX System is a computerized multi-technology platform that generates Laser, IPL, and RF energies for dermatological and surgical treatments. Depending on the applicator used, it treats hair removal, vascular lesions, pigmented lesions, muscle pain/spasm, and performs soft tissue coagulation and hemostasis.

The primary difference from the predicate InMode Multi-System is cosmetic industrial design (console color, LCD touchscreen placement, handpiece holder location) and an operating system upgrade from Windows CE to Linux. Critical system components, handpiece connectors, and operating parameters remain unchanged except for increased IPL Charger maximum output voltage. Handpiece housings changed from white to black coloring, and Morpheus8 power levels were restricted by treatment depth and operating mode.

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; IEC 60825:2007-03.

Indications for use are identical to predicate devices with their respective handpieces. Although the console design and operating system were modernized, the functional specifications of critical components, handpiece interfaces, and treatment parameters remain substantially unchanged. Software validation testing confirmed new Morpheus8 Burst and Scale Modes function as intended, and electrical testing to updated IEC standards demonstrates safety and performance equivalence to predicate devices.