R2 Technologies Inc, a provider of CryoAesthetic medical devices, announces that its in-office system, Glacial Rx, is now FDA-cleared for general dermabrasion, scar and acne scar revision, and tattoo removal.
The system was previously FDA-cleared to remove benign lesions and temporarily reduce pain, swelling and inflammation, according to the San Ramon, Calif-based company in a news release.
“This additional FDA clearance is a huge win, and not an easy feat. It took innovation, dedication, time, and resources. The clearance had an exceptional outcome in which we went from being part of one classification, among hundreds of other devices, to being placed in our very own FDA-issued product code.”
— Tim Holt, R2 Technologies Chief Executive Officer
“R2 has been at the forefront of the med-esthetics space since inception with its unmatched technology and continues to lead advancements in the industry. We are excited to see the company break boundaries yet again with its latest indication.”
— David Present, MD, and Cherine Eldumiati Plumaker, R2’s Chairman and Vice Chairman, respectively
In conjunction with the commercial launch, R2 has established a Scientific Advisory Board featuring industry veterans such as the inventors of the Glacial Rx technology: Rox Anderson, MD, Dieter Manstein MD, PhD, and Henry Chan, MD, PhD.
“With the appointment of our new Scientific Advisory Board, R2 is tapping into years of knowledge and expertise to launch new groundbreaking innovations, develop a superior product pipeline, and leverage technical insights to secure new clinical indications and expansion opportunities,” Holt adds.
[Source: R2 Technologies]