Sculpsure Cleared to Treat Double Chins
Cynosure's SculpSure is now cleared for submental fat reduction. The FDA granted an expanded FDA 510(k) clearance for this area, Hologic, Inc. reports. This is the device's sixth cleared body treatment area. SculpSure is also cleared to treat the abdomen, love handles, back, and inner and outer thighs.
Most patients in the 57-person clinical trial received two brief treatments six weeks apart. “The short treatment time, 100% satisfaction rate, and dramatic contour reductions typically seen in the study patients give SculpSure the edge as the treatment of choice for the submental area,” says Lawrence Bass, MD, New York City plastic surgeon and a principal investigator in the SculpSure clinical trials, in a news release.
FDA Clears Fotona's StarWalker MaQX Ultra Performance Q-Switched System
The FDA has cleared Fotona's StarWalker MaQX Q-Switched laser system for treating tattoos, pigmented and vascular lesions, acne and scar revision, and permanent hair reduction. The Verde 532 mode in a “tattoo laser” is exclusive to the MaQX. Sales in the US will begin immediately. The advancements of the StarWalker MaQX include clinical versatility, high power and performance, ergonomic compact size, 110v or 220v and an intuitive, interactive touch screen with user-friendly application wizards.
Internationally, Fotona launched its StarWalker MaQX laser system at the IMCAS 2017 world congress in Paris.
Solta Medical's Thermage FLX System Cleared
The FDA granted 510(K) clearance to Solta Medical's new Thermage FLX System for smoothing skin on the face, eyes, and body.
The Thermage FLX features a new optimized energy delivery algorithm, known as AccuREPTM technology, which automatically measures and precisely tunes the amount of energy delivered to the patient and treatment area. The system also features a new vibrating hand-piece to help enhance patient comfort, and a new, larger treatment tip that reduces treatment time by 25 percent.
“Being among the first adopters of the technology, I have confidently used the system for over a decade, as it is the center-piece of a successful skin tightening program,” says Michael S. Kaminer, MD, founding partner of SkinCare Physicians in Chestnut Hill, MA.
Sciton Partners with the Young Survival Coalition
Sciton, Inc.'s Women's Health Group division and the Young Survival Coalition (YSC) are partnering to raise awareness about women's vaginal health, in particular, those who are recovering from breast cancer therapy.
The Project Pink diVa starts with manufacturing new bright pink diVa handpieces for new diVa providers. Sciton will also be donating five percent of each diVa module and each Strengthened Quartz Dilator during October and November 2017 to the Young Survival Coalition, with an initial donation goal of $25,000. The company will also give a percentage of customer purchases to YSC.
“Our company's mission is based on the foundation of ‘Because Results Matter.' Sciton continues to focus and drive research and development efforts to products that provide options that serve people in enhancing their health and quality of life,” says Daniel Negus, President of Sciton, in a news release. “Sciton established the Women's Health Group division to further these goals in this market space. The partnership with YSC plays an integral role in the company's philanthropic mission.”