Cynosure Pellevé

Pellevé is a radiofrequency wrinkle treatment system that Ellman International developed around its Surgitron electrosurgical generators. FDA cleared Ellman's non-ablative wrinkle technique for the Surgitron IEC generator under K082834 in May 2009. A later filing describes the generator running at 4 MHz in a cut mode or a dedicated Pellevé mode, with energy delivered through a hand-held electrode activated by a finger or foot switch. Cynosure bought substantially all of Ellman's assets in September 2014, and the Pellevé records in FDA's device database now list Cynosure as the company.

The clinical end of the system is the handpiece. The first version, covered by K101967 in August 2010, paired a reusable Pellevé electrode with Ellman's three-button fingerswitch handpiece. The GlideSafe handpiece followed under K102698, cleared in January 2011, with a spring-mounted electrode and a detachable cord. GUDID lists GlideSafe handpieces with 7.5, 10, 15 and 20 mm electrodes and classifies them as monopolar applicators, along with Pellevé Quick-Connect cables. In September 2013, K132665 removed the skin phototype I to IV limit from the indication, which now reads as non-ablative treatment of mild to moderate facial wrinkles and rhytids.

Generators come in two families. Earlier systems ran on the Surgitron 4.0 Dual RF, also called the Surgitron 120 IEC, which is a full electrosurgical unit for cutting and coagulation as well. In 2013 Ellman cleared the Surgitron 4.0 Dual RF S5 IEC, and GUDID lists Pellevé S5 generators under model IEC5P-ST in 110 volt US and 220 to 240 volt versions. The model on the rear label tells you which one you have, and a buyer will want to know whether the generator also does general electrosurgery.

List the generator model and voltage, every GlideSafe handpiece by electrode size, the cables, the footswitch and any neutral plate cable. Photograph each electrode face for pitting or residue, confirm the Pellevé mode appears on the display, and include service records.