Latest News - FDA Approval/Clearance
Tuesday, September 18, 2018 | FDA Approval/Clearance, Phase 3/4 Trials, PracticalDermatology.com, PracticalDermatology.com
New for EBD-Based Acne Care: Sebacia Microparticles Cleared
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. Se…
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Wednesday, September 05, 2018 | FDA Approval/Clearance, PracticalDermatology.com, Almirall, ThermiAesthetics
Thermi Debuts Arvati Platform
Thermi, an Almirall company, is launching Arvati, a next-generation 510K US Food and Drug Administration-cleared, true temperature-controlled radiofrequency platform that powers a range of Thermi proc…
Read the full storyTuesday, 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 …
Read the full storyWednesday, 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…
Read the full storyMonday, 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…
Read the full storyWednesday, 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…
Read the full storyWednesday, 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…
Read the full storyWednesday, 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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