Lutronic® Announces FDA Clearance for Healite II™, An Advanced 830 nm LED Phototherapy System
The HEALITE II, an 830 nm LED Phototherapy System, received FDA 510k clearance and is now available for sale in the US, following its successful global launch in Europe, the Middle East, Asia and South America.
Lutronic, a global leader of lasers and therapeutic devices for aesthetic and medical applications, announced today the Healite II™ is now available for sale in the US, following its receipt of the 510(k) clearance from the United States Food and Drug Administration (FDA). "The 830 nm LED phototherapy system will do well in the US market, appealing to physicians looking to expand their clinic’s services," stated Ann Marie Collier, Global Products & Marketing Officer, "with a wide range of applications including aesthetic, surgical, and even in geriatrics."
"LED phototherapy has been known in the market for many decades by virtue of its various therapeutic benefits. However we wanted our product to stand out from the low-powered and low-quality LED products prevailing in the current market," said R. G. Calderhead, Vice President of Medical and Scientific Affairs Division of Lutronic, "Healite II offers technological advances to ensure maximum energy delivery to the tissue and ease of use features that physicians will appreciate."
In the US, the 830 nm HEALITE II is cleared for use in temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue and temporarily increasing local blood circulation where applied. Each of these applications can be expanded into a variety of useful treatments. Prof. Won-Serk Kim, Associate Prof. and Chairman, Department of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, South Korea, revealed, "HEALITE II is a useful adjunct to almost any aesthetic treatment. It is so important now that I couldn’t imagine practicing aesthetic medicine without it. It brings benefits to everything from injectables to laser and light-based treatments." Healite II is an excellent adjunctive therapy for many procedures or can be used stand-alone.
In Europe, HEALITE II received CE clearance for wound healing, skin rejuvenation and pain relief. Dr. Franco Lauro, Plastic Surgeon, Casa Di Cura Villa Torri, Italy, stated "HEALITE II can reduce patient downtime consistently by 30% to 40%. It is unique and has virtually no competition. I can use it anywhere but I see the best response on the face and neck." Although such indications have not yet received FDA clearance in the United States, Lutronic is currently working on obtaining these clearances through a variety of clinical evaluations.
About HEALITE II
HEALITE II is a Light Emitting Diode (LED) phototherapy system that is globally available with three different wavelengths: 830 nm, 633 nm, and 415 nm*. It can be used as a stand-alone therapy or adjunctive to a wide variety of treatments, including aesthetic laser treatments. Each wavelength targets various different indications. Patients of all ages and skin types can benefit from the pain free, athermal and easy to apply Healite treatments. HEALITE II is a 'must-have' device for all clinics looking to improve patient services, minimize downtimes, enhance recovery and complement other treatments.
Important features of HEALITE II are seen as below:
- 1800 durable, high quality LEDs
- Optical Lens Array Technology (OLAT) for improved photon intensity
- Ergonomic design
- Fully adjustable head, panels and arm
- Distance sensor
- User-friendly touchscreen
- Stable and easy to maneuver
*HEALITE II received CE marking in April 2011 and its 510(k) in June 2012; FDA clearance is limited to only the 830 nm wavelength at this current time.
To learn more about the HEALITE II please visit: www.lutronic.com/healite
Lutronic, a leading innovator in advanced aesthetic and medical laser and related technology, was established over 15 years ago to bring intuitive, robust, versatile devices that are affordable and efficacious to the worldwide medical community. Committed to improving medicine, Lutronic partners with key opinion leaders to advance science and ensure the efficacy of its systems. All systems are versatile and offer multiple setting and treatment options for customized treatments, which optimize outcomes for a wide variety of conditions and treatments including melasma, tattoo removal, soft tissue incision, vascular lesions, hair removal, wrinkle reduction, skin resurfacing, body/facial contouring, chronic pain and more.
With a focus on physician needs and patient outcomes, Lutronic dedicates time and funding toward the development of devices that offer features and improvements not found in today’s market. Devoting more than 15% of revenues to R&D, Lutronic holds more than 130 current and pending patents worldwide. With more than 230 employees worldwide, Lutronic has offices in the US, Korea, China, Japan, and Europe, a worldwide network of distributors, focused R&D centers in both the US and Korea, and is ever expanding.
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