InMode Fractora

Fractora is a fractional radiofrequency system that started life at Invasix, the Israeli company renamed InMode in November 2017. FDA cleared the original Fractora under K102461 in June 2011 for dermatological procedures that require ablation and resurfacing of the skin. That summary describes a console, a hand-held applicator and a disposable tip that sends bipolar RF current into the skin through an array of multi-electrode pins, with the Matrix RF applicator as predicate. InMode's annual report dates the Fractora handpiece to 2011 and says it received FDA clearances in 2011 and 2016.

The name later moved onto InMode's shared consoles. The 2016 clearance, K151273, covers the InMode FRF Applicator on the WMFace console: 1 MHz RF, up to 65 W, and a disposable, single-use tip with a 24 electrode pin array. Above 62 mJ per pin its use is limited to skin types I to IV. In 2018 FDA cleared the Fractora3D and 3D-90 applicators under K180189 on the same platform, again with 24-pin single-use tips. InMode's report describes Fractora as offering two treatment depths, at the skin surface and subdermal, with a consumable tip holding 24 coated pins up to 4 mm long.

Sellers often aren't sure whether they own a Fractora or something newer. In December 2019 FDA cleared K192695, the InMode System with the Morpheus8 (Fractora) applicators, and Morpheus8 is the name InMode uses for its fractional RF microneedling today. A women's health version called FractoraV was sold with InMode's Votiva platform. Write down the name printed on each applicator and on your tip packaging, and read the platform name from the console's serial label.

Because every treatment uses a single-use pin tip, a buyer will ask how many sealed tips come with the system, which tip types they are and when they expire. Also list each applicator by model, the console name from the serial label, the footswitch, cables, software version and service history. Photos of the console label and each applicator help.