Showing 21-30 of 47 results for "".
- Sculpture OK'd as Double Chin Treatmenthttps://modernaesthetics.com/news/sculpsure-oked-as-double-chin-treatment/2472190/Cynosure's SculpSure® is now cleared for submental fat reduction. The U.S. Food and Drug Administration (FDA) granted an expanded FDA 510(k) clearance for this area, Hologic, Inc. reports.
- AEON 'Aligned' With FDA for Botox Biosimilarhttps://modernaesthetics.com/news/aeon-aligned-with-fda-for-botox-biosimilar/2473682/AEON Biopharma, Inc., a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, announced receipt of the formal minutes from a recent Biosimilar Initial Advisory (BIA) Meeting with the US Food and Drug Administration (FDA) for AB
- Venus Concept Introduces Medical Advisory Board for AI.MEhttps://modernaesthetics.com/news/venus-concept-introduces-medical-advisory-board-for-aime/2473449/The primary mission of the medical advisory board will be to provide strategic input, guidance, and clinical recommendations regarding the Company's emerging robotic technology, AI.ME, which received its first 510(k) clearance from the U.S. Food and Drug Administration (FDA) in December 2022,
- FDA Clears Apyx Medical’s Renuvion Handpiece for Improving Lax Skinhttps://modernaesthetics.com/news/fda-clears-apyx-medicals-renuvion-handpiece-for-improving-lax-skin/2473268/The U.S. Food and Drug Administration received 510(k) clearance for the use of Apyx Medical’s Renuvion APR Handpiece for certain skin contraction procedures. Specifically, the Renuvion APR Handpieces are now indicated for use in subcutaneous dermatological and aest
- Alma Hybrid Launcheshttps://modernaesthetics.com/news/alma-hybrid-launches/2473128/Alma Hybrid™, the first laser platform to include an ablative 10,600nm (CO2) laser and a non-ablative 1570nm laser for skin resurfacing, in launching in the US. The system received FDA 510(k) clearance. Alma Hybrid offers p
- Allergan to Buy Soliton and Resonic, Its Rapid Acoustic Pulse Devicehttps://modernaesthetics.com/news/allergan-to-buy-soliton/2473103/Allergan Aesthetics is set to acquire Soliton and Resonic, its Rapid Acoustic Pulse device. Resonic recently received U.S. Food and Drug Administration (FDA) 510(k) clearance and is a non-invasive treatment for the short-term improvement in the appearance of cellulite. The acquisition o
- NYC Plastic Surgeon Dr. Sachin Shridharani Joins Soliton’s Scientific Advisory Boardhttps://modernaesthetics.com/news/sachin-shridharani-md-joins-solitons-scientific-advisory-board/2472973/Sachin Shridharani, MD has joined Soliton, Inc’s Scientific Advisory Board. Soliton, Inc. recently filed for 510(k) premarket clearance with the U.S. Food and Drug Administration (FDA) of its second-generation Rapid Acoustic Pulse (RAP) device for the reduction in the appearance o
- FDA Clears Bimini Health Tech’s Dermapose Access Office-Based Fat Harvesting Systemhttps://modernaesthetics.com/news/fda-clears-bimini-health-techs-dermapose-access-office-based-fat-harvesting-system/2472922/Bimini Health Tech’s received US Food and Drug Administration (FDA) 510(k) clearance for its Dermapose Access, a novel fat harvesting system. Designed for office use, the launch of the Dermapose Access system creates a new pr
- FDA Clears Wontech’s Sandro Dual Laserhttps://modernaesthetics.com/news/fda-clears-wontechs-sandro-dual-laser/2472905/The U.S. Food and Drug Administration granted 510 (K) marketing clearance to Wontech’s Sandro Dual, a hybrid Nd:YAG & Alexandrite laser device. In the hybrid mode, by irradiating a short time difference between two wavelengths of 755nm and 1064nm, the laser accurately hits its
- New for EBD-Based Acne Care: Sebacia Microparticles Clearedhttps://modernaesthetics.com/news/new-for-ebd-based-acne-care-sebacia-microparticles-cleared/2472033/Sebacia Microparticles are now FDA-cleared for use in the treatment of acne. The clearance comes on the heels of a pivotal study demonstrating the clinical safety and efficacy of the micoparticles. Sebacia, Inc. had submitted its 510(k) submission to the FDA in June 2018. Sebacia Mic