Showing 521-530 of 1364 results for "".
- 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
- San Francisco Dermatologist Bill Kwan Featured in Third Albumhttps://practicaldermatology.com/news/san-francisco-dermatologist-bill-kwan-featured-in-third-album/2460773/As a dermatologist, Bill Kwan, MD plies his craft as the provider of both medical and aesthetic care to patients in San Francisco. As a vocalist, he plies his craft sharing the art of music. Dr. Kwan has released "No Ordinary Love: The Music of Sade." The third album that features Dr. K
- 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
- FDA Clears LASEROPTEK's HELIOS IV-785 for Aesthetic and Medical Dermatology Usehttps://practicaldermatology.com/news/fda-clears-laseropteks-helios-iv-785-for-aesthetic-and-medical-dermatology-use/2461326/The U.S. Food and Drug Administration has granted 510(k) clearance to LASEROPTEK Co., Ltd.’s HELIOS IV-785 laser system for aesthetic and medical dermatology applications. HELIOS IV-785's novel and synergistic combination of 785nm picosecond photoacoustic effect and 1064 &
- FDA Clears Use of Apyx Medical’s Renuvion Handpiece for Improvement in Appearance of Lax Skinhttps://practicaldermatology.com/news/fda-clears-use-of-apyx-medicals-renuvion-to-improve-appearance-of-lax-skin/2461273/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
- Health Canada Clears Cutera’s AviClearhttps://practicaldermatology.com/news/health-canada-clears-cuteras-aviclear/2461268/Health Canada has cleared Cutera, Inc.’s AviClear for the treatment of mild, moderate, and severe acne. This Health Canada announcement comes on the heels of the U.S. Food and Drug Administration’s 510(k) clearance of AviClear, in March 2022. In addition
- DERMWIRE Exclusive: FDA Clears Cutera’s AviClear Acne Devicehttps://practicaldermatology.com/news/dermwire-exclusive-fda-clears-cuteras-aviclear-acne-device/2461124/The U.S. Food and Drug Administration has cleared granted 510(k) clearance to Cutera’s AviClear acne device. This is the first energy device to receive a nod for the treatment of mild, moderate, and severe acne. AviClear targets acne at the source by selec