TauTona Group said the FDA has given 510(k) clearance for the company’s tissue injector.
The device is the 2nd from Edison Park, Calif.-based TauTona. The single-use, hand-held injector is designed to simplify fat grafting through an even, controlled rate so the surgeon can focus on placement of the fat, according to a press release.
“At TauTona we believe the absence of a specialized fat grafting tool has made it more difficult for surgeons to provide their patients with precise, repeatable results," managing partner Dr. Geoffrey Gurtner said in prepared remarks. "Our hope is that the TTI will allow physicians to improve the procedure’s efficiency and ergonomics by reducing the time to re-injection. We believe that an effective fat transfer tool could increase the number of physicians using the technique and increase the number of procedures performed."