Ellman International Enters Body Treatment Market Receives FDA Clearance for PelleFirm and is Now CE Marked
HICKSVILLE, N.Y., Feb. 27, 2014 /PRNewswire/ -- Ellman International, Inc., a global leader in advanced radiofrequency (RF) and laser technology for precision surgical and aesthetic procedures, announced today that the company has received clearance from US Food and Drug Administration (FDA) to market its new PelleFirm™ RF Body Treatment System. The PelleFirm System is CE Marked for body skin tightening and cellulite reduction. In addition, it also has received FDA 510(K) clearance for tissue heating and the temporary reduction in the appearance of cellulite.
The PelleFirm System provides a non-invasive, pain free RF treatment for the body, resulting in firmer skin and the impermanent reduction in the appearance of cellulite. The company leveraged its expertise in RF based skin tightening with Pelleve® in the development of PelleFirm. The system is comprised of 2 new, large diameter handpieces sized for the body that elevate tissue temperature up to 45 degrees Celsius, coupled with mechanical massage heads for treatment of areas with cellulite. PelleFirm is ideal for problem zones including the abdomen, arms, buttocks and thighs.
The PelleFirm handpieces are powered by the Pelleve S5 RF Generator, which also powers the Pelleve Wrinkle Reduction handpieces for facial skin tightening. These new PelleFirm RF Body treatment devices are compatible with the recently released Enhanced Pelleve S5 Generator, as well as the large worldwide installed base of the original Pelleve S5 Generators from Ellman.
"We have been working with physicians around the world to develop PelleFirm and are excited to bring this innovative RF Body treatment system to market. It addresses the need for an effective, non-invasive body solution," commented Frank D'Amelio, President & CEO. "With two different size handpieces, PelleFirm can address almost every area of the body. Like Pelleve, a PelleFirm RF Body Treatment system delivers visible results with no pain and no downtime."
Josephine Hernandez, MD, a Dermatologist and a primary PelleFirm clinical investigator, said, "Many of my patients request treatment for sagging skin in their arms, hands, abdomen, thighs and gluteal area." She commented further, "The results (with the PelleFirm system) are outstanding and superior to any of the many body contouring or skin tightening devices we have used in our practice. I have seen PelleFirm results in as little as a few treatments. We are very satisfied users."
Ellman has received advance orders from enthusiastic international distributors and will formally launch the PelleFirm System to the US and international markets at the upcoming Annual Meeting of the American Academy of Dermatology (AAD), beginning March 21, 2014 in Denver, CO.
About Ellman International, Inc.
Ellman International, Inc., a New York based manufacturer of medical devices serves the global aesthetic, multi-specialty surgical, dental and veterinary markets with a full complement of affordable advanced radiofrequency (RF) and laser products for precision surgical and aesthetic procedures. Ellman is recognized as a pioneer in the development of specialized radiofrequency technology for precision cutting, coagulating and tissue ablation in physicians' offices, clinics and surgical centers. The Company provides a wide range of products that are used in the non-surgical and surgical procedures in over 65 countries.
In 2009, the Company leveraged the versatility of its unique radiofrequency platform and the legacy Surgitron® surgical line of products to develop the Pelleve® Wrinkle Reduction System. Pelleve is a revolutionary skin tightening system for non-ablative skin rejuvenation that can be performed in an hour or less, is pain free and is associated with no downtime for the patient. In 2012 Ellman enriched its aesthetic product portfolio by adding a line of laser and IPL systems with the acquisition of Sandstone Medical Technologies.
Ellman is primarily owned by Baird Capital, Chicago, IL. For more information, visit www.ellman.com.
 Note: International indications for use differ from the indications cleared by FDA. The following indications are cleared by FDA: The PelleFirm RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The PelleFirm massage device is intended to provide a temporary reduction in the appearance of cellulite.
SOURCE Ellman International, Inc.