Lumenis - FDA 510(k) Cleared Devices

Lumenis, is a global leader in energy-based medical device solutions for aesthetic and vision care. The company develops and commercializes innovative laser, intense pulsed light (IPL), and radiofrequency technologies with a manufacturing facility in Pleasanton, California.

Lumenis has received 5 FDA 510(k) clearances from 5 total submissions, with all devices focused on General & Plastic Surgery applications. The company's regulatory clearance history spans from 2001 to 2010, establishing a strong foundation in minimally invasive surgical and aesthetic treatments.

Historical FDA 510(k) cleared devices include CO2 laser systems, IPL and combination IPL/Nd:YAG systems, holmium and dual-wavelength surgical lasers, and specialized phototherapy systems. These technologies support a broad range of dermatological and surgical procedures including skin resurfacing, hair removal, vascular lesion treatment, and tissue ablation.

Lumenis maintains a significant global installed base exceeding 80,000 systems across more than 100 countries. For detailed information on specific device names, product codes, and individual 510(k) clearance dates, please explore the regulatory database.