Lutronic® Announces FDA Clearance for INFINI™, an Ideal Solution for Wrinkle Reduction through 3-D Volumization
Lutronic, a global leader of lasers and therapeutic devices for aesthetic and medical applications, announced today that the INFINI™ is now available for sale in the USA, following its receipt of the 510(k) clearance from the United States Food and Drug Administration (FDA). "The INFINI is a device that provides a new dimension in RF technology that will be well received by USA physicians and patients alike,” stated Ann Marie Collier, Global Products & Marketing Officer. “Previously released outside of the USA, the Infini is clinically proven in Europe, Asia, the Middle East and South America and has enabled Investigators and Customers to perform thousands of procedures. Their collective input indicates Infini has many technologically advanced features physicians appreciate and clinical outcomes their patients love, for a positive impact on clinic business.”
Infini’s approach is an ideal solution to create targeted coagulation zones in aging, sagging skin with wrinkles. Complete control over treatment depth and energy levels enables a multi-layered treatment approach with no electrothermal damage to the epidermis.
“Infini’s proven design delivers improved wrinkle reduction through 3-dimensional energy delivery to volumize tissue and deliver improved outcomes for a broad range of skin types, including darker skin types and tanned skin,” said R. Glen Calderhead, PhD and Vice President of Scientific Affairs at Lutronic. “Infini can deliver the RF energy into the dermis up to 3.5 mm deep, which has many clinical benefits. Adjustable target depth control allows for precise and controllable fractionated coagulation zones within a specific layer of the dermis; physicians can choose to provide mild to aggressive treatments, even in delicate areas. Additionally, the treatment is well tolerated by patients, thanks to the ComfortFlow™ technology.”
Built-in ComfortFlow technology minimizes patient discomfort and allows for quick and easy recovery. “The serial needle insertion, or flow needle technology, provides a more comfortable treatment for the patient,” stated Dr. Franco Lauro, Plastic Surgeon, Bologna, Italy, stated, “INFINI has had a tremendously positive effect [on my clinic]. It is so well accepted by patients that we’ve performed more than 500 treatments in [the first] six months.”
The Infini is an ideal year round treatment solution. The direct dermal energy delivery allows physicians to treat patients with darker or tanned skin, and effectively lowers the risk of PIH. “I can go 3.5 mm deep in skin without hurting the epidermis; …help with deep wrinkles and many other treatments that you want to perform, [while] avoiding post-inflammatory hyperpigmentation,” stated Dr. Ivan Perez, Chief Dermatology Section Fundación Santa Fé de Bogotá, Colombia.
The Lutronic INFINI is an advanced Fractional Radio Frequency (FRF) device developed specifically to be safe for all skin types, all year. Infini provides wrinkle reduction through 3-dimensional energy delivery to volumize tissue. Fractional RF is the latest technology developed to work within the dermis to stimulate collagen at the source while lowering the risk of thermal damage to the epidermis.
The robust Infini has a long list of features that support physicians and their patients’ needs.
- Ergonomically designed lightweight handpiece
- Precise targeting with adjustable microneedles up to 3.5 mm
- Hand or footswitch operated
- Intuitive touch screen
- Patented ComfortFlow Technology
Infini received CE marking in 2011 and FDA 510(k) clearance in June 2013.
To learn more: www.lutronic.com/INFINI
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 20% 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, and is ever expanding.