Showing 11-20 of 65 results for "".
- FDA Grants 510(k) Clearance to Laseroptek's PicoLOhttps://practicaldermatology.com/news/fda-grants-510k-clearance-to-laseropteks-picolo/2459903/Laseroptek’s PicoLO picosecond Nd:YAG laser is now U.S. Food and Drug Administration-cleared for marketing in dermatology and general and plastic surgery. According to the company, PicoLO generates high peak power and consistent picosecond pul
- Pulse Biosciences Scores FDA 510(k) Clearance of Expanded Energy Settings for CellFX Systemhttps://practicaldermatology.com/news/pulse-biosciences-scores-fda-510k-clearance-of-expanded-energy-settings-for-cellfx-system/2461289/The U.S. Food and Drug Administration (FDA) gave 510(k) clearance tp expanded energy settings for use with Pulse Biosciences, Inc.’s CellFX System treatments tips in dermatology. “Pulse Biosciences is dedicated to providing dermatologists a superior solution for the treatmen
- Bimini Health Tech’s Dermapose Access Office-Based Fat Harvesting System Scores FDA 510(k) clearancehttps://practicaldermatology.com/news/bimini-health-techs-dermapose-access-office-based-fat-harvesting-system-scores-fda-510k-clearance/2460368/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 sy
- Apyx Medical Corporation Receives FDA 510(k) Clearance for Renuvion Handpiecehttps://practicaldermatology.com/news/apyx-medical-corporation-receives-fda-510k-clearance-for-renuvion-handpiece/2461216/The U.S. Food and Drug Administration has granted marketing clearance to Apyx Medical Corporation’s Renuvion Dermal Handpiece for specific dermal resurfacing procedures. The Renuvion Dermal Handpiece is indicated for dermatological procedures for the treatment of moderate to
- FDA Grants 510(k) Clearance to Chemence Medical’s Exofin Fusion Redesignhttps://practicaldermatology.com/news/fda-grants-510k-clearance-to-chemence-medicals-exofin-fusion-redesign/2460736/The U.S. Federal Drug Administration gave its nod to Chemence Medical’s redesigned exofin fusion skin closure system. Exofin fusion combines a self-adhering flexible mesh strip and a fast-curing 2-octyl cyanoacrylate topical adhesive to close and seal incisions while forming an im
- US FDA Issues Draft Updated Recommendations on Submitting a New 510(k) for Device Modificationshttps://practicaldermatology.com/news/us-fda-issues-draft-of-updated-recommendations-on-submitting-a-new-510k-for-device-modifications/2458471/The U.S. Food and Drug Administration (FDA) issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made
- Sculpsure Cleared to Treat Double Chinshttps://practicaldermatology.com/news/sculpsure-cleared-to-treat-double-chins/2458036/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.
- Novartis receives FDA regular approval for Tafinlar + Mekinist for Melanomahttps://practicaldermatology.com/news/novartis-receives-fda-regular-approval-for-tafinlar-mekinist-for-melanoma/2458804/The FDA granted regular approval for the combination of Tafinlar® (dabrafenib) + Mekinist® (trametinib) from Novartis for the treatment of patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test. This is th
- FDA Clears Xstrahl’s Radiant Aura for NMSCshttps://practicaldermatology.com/news/fda-clears-radiant-aura-receives-us-food-and-drug-administration-fda-510k-clearance/2461871/The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Xstrahl’s Radiant Aura, an office-based radiation therapy for non-melanoma skin cancer (NMSC). “We developed Radiant Aura to deliver both electronic brachytherapy and superficial radiation therapy in
- FDA Clears CellFX System for the Treatment of SHhttps://practicaldermatology.com/news/fda-clears-cellfx-system-for-the-treatment-of-sh/2461358/The U.S. Food and Drug Administration (FDA) granted Pulse Bioscience’s CellFX System (FDA) 510(k)marketing clearance for the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-II. This specific indication clearance enhances the CellFX