BTL Exilis

Exilis is the radiofrequency system that started BTL's Exilis line. FDA cleared it as the Exilis, Model 5000 under K092191 on November 25, 2009, with the summary also using the name EXILIS 5000. The clearance falls under product code GEI, the electrosurgical category, and covers non-invasive dermatologic and general surgical procedures for wrinkles and rhytids, with therapy applied through a high frequency field. The predicates named were the Thermage ThermaCool, the Alma Accent and the Iskra Medical Green IRF Prestige.

According to the 2009 summary, the console stands upright and has a color touch screen worked with a stylus. The applicator has its own buttons and a display that shows the set and measured values, so the operator can adjust treatment without reaching for the console. Patient names can be stored in the system's memory and linked to preset or custom protocols. The console sits on a purpose built cart with four castors.

BTL kept the name through later generations, which helps when dating a unit. The Exilis XP, cleared in January 2015 (K143040), has an 8.4 inch touch screen, an illuminated treatment tip that shows energy flow, contact quality monitoring under a patch electrode and two massage heads. It was cleared for tissue heating for pain relief, muscle spasm and circulation, and its massage function for a temporary reduction in the appearance of cellulite. The Exilis XP II, cleared in January 2017 (K163176), added exchangeable single use applicator tips. The FDA device database also has separate records for the Exilis Protégé, Exilis Ultra and Exilis Ultra 360, along with an Exilis large applicator (215/1) and small applicator (215/2).

A stylus and upright cabinet point to the original, massage heads point to an XP, and exchangeable tips to an XP II. Photograph the rear label with its model number, every applicator label and the main screen. Include any patch electrode and cables, the software version and service history, and clear stored patient records before sale.