InMode Votiva

Votiva is InMode's first platform for women's health. InMode's 2019 IPO prospectus says the platform launched commercially in the third quarter of 2017, and its annual reports describe Votiva and the later EmpowerRF, introduced in 2021, as the company's two women's health platforms. Votiva uses bipolar radiofrequency through handpieces that heat tissue non-invasively or treat it with fractional RF.

The core handpiece is FormaV, introduced in 2017, which uses InMode's ACE technology to deliver auto-adjusting, uniform RF heating. The fractional handpiece sold with early systems was FractoraV, and by 2019 InMode described Votiva as including FormaV and Morpheus8. InMode's annual report identifies the console as the InMode Plus90 (Votiva) platform when it cites the FormaV indication for temporary relief of minor muscle aches and pain. FDA's December 2017 clearance K172302 for the InMode PLUS System gives the underlying parameters: RF power adjustable from 10 to 50 W, a skin temperature cutoff adjustable from 35 °C to 42 °C, handpieces kept in continuous motion over the treatment area, and three handpiece options, PLUS, PLUS90 and PLUS-PLUS.

In July 2018 InMode received an FDA letter asking for the regulatory basis on which it marketed FormaV and FractoraV. InMode replied that FormaV was cleared for temporary relief of minor muscle aches and pain and that FractoraV was cleared for dermatologic and general surgical electrocoagulation and hemostasis. Because InMode handpieces run on more than one console, the platform name on the serial label is the surest way to tell a Votiva from an EmpowerRF.

For a buyer the handpiece list does most of the talking. State whether you have FormaV, FractoraV, Morpheus8 or a combination, and list any sealed tips or applicators with expiry dates. Include the software version, the service history, the condition of cables and connectors, and any error codes. Photos of the serial label, the touchscreen and each handpiece label let a dealer check the configuration before making an offer.