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FDA expands indications for SculpSure

SculpSure FDA approved

The U.S. Food and Drug Administration granted an expanded FDA 510(k) clearance in September for Cynosure’s non-invasive body contouring product, SculpSure. This body contouring laser treatment is now cleared to treat the submental area. SculpSure has also been cleared to treat the abdomen, flanks, back, and inner and outer thighs. …

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FDA Clears Xstrahl Photoelectric Therapy System

fda approved Xstrahl

Xstrahl has received FDA 510K clearance for the marketing of its latest skin cancer therapy device. The Photoelectric Therapy System is a compact and ergonomic superficial X-Ray therapy system operating in the 10kV to 80kV range intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms …

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Sonoma Pharmaceuticals Launches Loyon

Sonoma Pharmaceuticals Launches Loyon

Sonoma Pharmaceuticals, Inc. has begun US commercialization of the company’s new Loyon® product. Under the supervision of a healthcare practitioner, Loyon is intended to manage and relieve the scaling, erythema, and itching associated with various types of dermatoses including seborrhea and seborrheic dermatitis. Loyon is a unique, patented combination of …

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Meet Thermage’s New FLXTM System

Thermage’s New FLXTM FDA

The U.S. Food and Drug Administration (FDA) 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, known as AccuREPTM technology, which automatically measures and precisely tunes the amount of energy delivered to …

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