Tele: 561.316.3330
Breaking Medical Device News

Monday, October 18, 2021
HomeFDASoliton Receives FDA Acceptance for 510(k) Application

Soliton Receives FDA Acceptance for 510(k) Application

Rapid Acoustic Pulse ("RAP") Device 510(k) Application Accepted for Cellulite Reduction

July 15, 2020

Soliton, Inc., today announced that it’s 510(k) application for premarket clearance filed with the U.S. Food and Drug Administration (“FDA”) for its second-generation Rapid Acoustic Pulse (“RAP”) device for cellulite reduction has cleared the agency’s acceptance review. The application now moves to a substantive review.

Solition notes the device is already indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients and this latest new application is for the temporary improvement of the appearance of cellulite.

Clinical trials have demonstrated an average 32.5% improvement in the Cellulite Severity Score in our subjects and strong patient satisfaction with 91.9% of subjects agreeing or strongly agreeing that their cellulite appeared improved. Further, there were no unexpected or serious adverse events and the average pain scores were 2.4 on a 10-point scale.

Dr. Christopher Capelli, president and CEO of Soliton, said, “We are very pleased with the progress of our  premarket notification through the FDA review process.” Dr. Capelli continued, “Having found that our submission contained all the necessary elements and information, we look forward to the substantive review and FDA clearance of the RAP device.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy