Hologic, Inc.’s Cynosure division is launching the U.S. Food and Drug Administration (FDA)-cleared TempSure Surgical RF technology in North America. This is a new offering for the TempSure radiofrequency (RF) platform that provides clinicians the ability to perform both surgical and non-surgical aesthetic procedures across a variety of specialties, on a single device.
Cynosure also has returned TempSure Vitalia hand pieces and probes to the market and will continue to market its MonaLisa Touch CO2 laser following the FDA inquiry on products used in energy-based women’s health procedures. Cynosure has worked closely with the FDA and reviewed and updated all its marketing and promotional materials to ensure they are consistent with the FDA’s labeling expectations in recent months.
TempSure Surgical RF technology harnesses a 300-watt and 4-MHz radiofrequency platform that enables precise incisions with minimal lateral thermal damage to surrounding tissues. The resulting high-quality coagulation lessens sparking and charring during procedures, which promotes quicker recovery and better healing for patients. The device is designed to improve patient satisfaction and aesthetic outcomes, and can be used by clinicians across a variety of specialties including plastic surgery, dermatology, gynecology and ophthalmology. TempSure Surgical RF technology is designed to enhance the existing TempSure radiofrequency platform, and includes a variety of electrodes that integrate seamlessly with the main TempSure unit.
In January 2018, Cynosure launched the TempSure radiofrequency platform with TempSure Envi, a device for treating facial fine lines and wrinkles, tightening the skin through soft tissue coagulation, and temporarily reducing the appearance of cellulite. New and existing customers now have the opportunity to customize their TempSure Envi system to include TempSure Surgical RF technology, TempSure Vitalia hand pieces, or a combination of all three to help meet different clinical needs at their practice.
“We’re continually innovating to ensure our customers set themselves apart with effective and diverse treatment offerings, and this enhanced platform is a gamechanger across specialties,” says Kevin Thornal, Hologic's Division President of Cynosure in a news release. “We’re pleased to reintroduce TempSure Vitalia and to continue offering MonaLisa Touch to provide clinically strong products for women’s wellness. Cynosure is the only medical aesthetic manufacturer to offer two different energy-based modalities for women’s wellness — radiofrequency and CO2 — and we remain committed to advancing women’s pelvic health around the globe.”