Latest News - FDA Approval/Clearance

Tuesday, July 31, 2018 | FDA Approval/Clearance, PracticalDermatology.com

FDA: Energy-Based Vaginal Rejuvenation May Cause Burns, Scarring

The FDA is cracking down on the use energy-based devices to perform vaginal 'rejuvenation.' The use of such devices to perform vaginal "rejuvenation," cosmetic vaginal procedures,…

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Monday, July 16, 2018 | FDA Approval/Clearance, Personnel/Company News, PracticalDermatology.com, Product Launches and Updates

Candela Launches Vbeam Prima

Recently FDA-cleared, the Vbeam Prima from Candela offers two wavelengths to effectively treat a broad range of skin conditions including rosacea, spider veins, wrinkles, acne and …

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Friday, June 29, 2018 | FDA Approval/Clearance

FDA Approves Dermira's Qbrexza Cloth for Hyperhidrosis

A new hyperhydrosis treatment is now FDA approved. The FDA has approved Qbrexza™ (glycopyrronium) cloth, an anticholinergic indicated for the topical treatment of primary axillary hyperhidrosis …

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Wednesday, May 30, 2018 | FDA Approval/Clearance, Personnel/Company News, PracticalDermatology.com

Revance Vet Tapped as New Evolus CFO

Lauren Silvernail is the new Chief Financial Officer and Executive Vice President, Corporate Development at Evolus, Inc. Silvernail joins Evolus from Revance Therapeutics where she most recently se…

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Monday, May 21, 2018 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates

Restylane Lyft Now FDA-Approved for Hands

The US Food and Drug Administration has approved Restylane Lyft for use on the dorsal hands of people older then 21, making it the first hyaluronic acid (HA) injectable gel approved for this…

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Wednesday, May 16, 2018 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates

FDA Says No to Evolus' Botox Rival

The U.S Food and Drug Administration did not approve DWP-450, Evolus Inc's rival product to Allergan Plc's Botox, due to chemistry and manufacturing issues. As a result, the company pushed …

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Wednesday, February 21, 2018 | FDA Approval/Clearance, Research and Publications

Mentor: 10-Year Data Show Safety, High Satisfaction

Data from a 10-year clinical study involving 955 patients in the US suggests that  Mentor® MemoryShape Gel Breast Implants are safe and associated with high rates of physician and surgeon sat…

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Tuesday, December 12, 2017 | FDA Approval/Clearance, Allergan

CoolSculpting is Now FDA Approved to Improve Lax Tissue in Double Chin

The FDA has approved CoolSculpting treatment for the improved appearance of lax tissue in conjunction with submental fat, or double chin, treatments.  Allergan's CoolSculpting for the double …

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Monday, December 04, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Merz

FDA OKs Describe Patch for Use with All Tattoo Removal Lasers

Merz North America’s DESCRIBE® PFD Patch is now cleared by the Food and Drug Administration (FDA) for all commonly used lasers for tattoo removal. The new FDA clearance also extends …

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Thursday, October 12, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Galderma

Galderma's Restylane Silk Approved for Injection via Cannula for Lip Augmentation

The FDA approved the use of a small blunt tip cannula with Restylane Silk for lip augmentation. Galderma's Restylane Silk was the first FDA-approved hyaluronic acid (HA) dermal filler specifically…

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Wednesday, October 04, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Solta, Valeant NJ

FDA Clears Thermage’s FLX System for Smoothing Skin

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 fe…

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Wednesday, October 04, 2017 | FDA Approval/Clearance, Product Launches and Updates, Johnson & Johnson

MENTOR’s MemoryGel Xtra Breast Implants Hit US

Mentor Worldwide LLC’s MemoryGel® Xtra Breast Implants are now available in in the United States. MENTOR MemoryGel Xtra is being showcased at the 2017 Plastic Surgery Meeti…

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Tuesday, October 03, 2017 | FDA Approval/Clearance, Allergan

FDA Approves Botox Cosmetic for Moderate to Severe Forehead Lines

The FDA approved Allergan plc's Botox Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity …

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Wednesday, September 27, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Cynosure

Sculpture OK'd as Double Chin Treatment

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. rep…

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Wednesday, September 27, 2017 | FDA Approval/Clearance, PracticalDermatology.com

FDA Clears Fotona's StarWalker MaQX Ultra Performance Q-Switched System

The FDA has cleared Fotona's StarWalker MaQX Q-Switched laser system for treating tattoos, pigmented and vascular lesions, acne and scar revision, and permanent hair reduction. The Verde 532 mode …

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