Showing 541-550 of 1378 results for "".
- Soliton Seeks 510k Clearance for RAP Anti-Cellulite Devicehttps://practicaldermatology.com/news/soliton-seeks-510-clearance-for-rap-anti-cellulite-device/2460452/Soliton, Inc. 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 of cellulite. The RAP device was previously cleared by the FDA as an accessory to a 1064 nm
- Wontech Scores FDA Nod for Sandro Dual Laserhttps://practicaldermatology.com/news/wontech-scores-fda-nod-for-sandro-dual-laser/2460333/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
- FDA Clears Sebacia Microparticles for Laser-Based Acne Treatmenthttps://practicaldermatology.com/news/fda-clears-sebacia-microparticles-for-laser-based-acne-treatment/2457603/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
- Merix Pharmaceutical Corp: Releev Cold Sore Treatment Now in Convenience Storeshttps://practicaldermatology.com/news/merit-pharmaceutical-corp-releev-cold-sore-treatment-now-in-convenience-stores/2457644/Merix Pharmaceutical Corp’s Releev®1 Day Cold Sore Symptom Treatment is now available in convenience stores, including 7-Eleven and soon in Circle K in the United States. Releev
- Neova Introduces Clinical Recovery Creamhttps://practicaldermatology.com/news/neova-introduces-clinical-recovery-cream/2457654/Neova SmartSkinCare is launching its Clinical Recovery range of products. The line of six new products is formulated to keep skin calm, soothed, hydrated, and protected following microdermabrasion, laser resurfacing, chemical peels,K and laser hair removal treatments for increased rates of healin
- FDA Approves Sonoma Pharmaceuticals' Antimicrobial Post-Therapy Gelhttps://practicaldermatology.com/news/fda-approves-sonoma-pharmaceuticals-antimicrobial-post-therapy-gel/2457813/Sonoma Pharmaceuticals, Inc. has received a new 510(k) clearance from the FDA for an antimicrobial post-therapy gel. Under the supervision of a healthcare professional, the new product is intended for the management of post-non-ablative laser therapy procedures and post-microdermabrasion therapy
- gel-e Receives US FDA Clearance to Expand its Bandage Product Line for Rx, OTC Usehttps://practicaldermatology.com/news/gel-e-receives-us-fda-clearance-to-expand-its-bandage-product-line-for-rx-otc-use/2457951/The U.S. Food and Drug Administration (FDA) has cleared gel-e Inc.’s adhesive bandage for prescription (Rx) and over-the-counter (OTC) use. This 510(k) clearance expands the Company's label to include the ma
- Meet Thermage's New FLX Systemhttps://practicaldermatology.com/news/meet-thermages-new-flxtm-system/2458026/The US Food and Drug Administration granted 510(K) clearance to Solta Medical’s new Thermage FLXTM System for smoothing skin on the face, eyes, and body. The Thermage FLX features a new optimized energy delivery algorithm, know
- FDA Clears Philips BlueControl Wearable Light Therapy Device to Treat Mild Psoriasis At Homehttps://practicaldermatology.com/news/fda-clears-philips-bluecontrol-wearable-light-therapy-device-to-treat-mild-psoriasis-at-home/2458124/The FDA has granted Royal Philips 510(k) clearance to market the Philips BlueControl wearable light therapy device to treat mild psoriasis. In the US, BlueControl is a Class II prescription medical device designed for home use. Clinical studies have demonstrated that the UV-free blue LED
- FDA Clears Syneron Candela's Profound SubQ to Improve Cellulitehttps://practicaldermatology.com/news/fda-clears-syneron-candelas-profound-subq-to-improve-cellulite/2458381/Syneron Candela received FDA 510(k) clearance for Profound when using the SubQ handpiece and cartridge to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III, as supported by long term data (6 months). A recent multi-center clinical study of Profound sh