Latest News - FDA Approval/Clearance
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…
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 …
Read the full storyWednesday, 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 …
Read the full storyTuesday, September 26, 2017 | FDA Approval/Clearance
Federal Judge Orders Flawless Beauty to Stop Distributing Unapproved Drugs, Recall Certain Products
A federal judge ordered a New Jersey company that sold injectable skin whitening and other beauty products to stop selling and recall some of its products because they are unapproved new drugs that ma…
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Friday, June 23, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Tattoo
There’s a New Pico in Town: Wontech’s Picocare Scores FDA Nod
The U.S. Food and Drug Administration (FDA) cleared WONTECH’s picosecond laser device for tattoo removal. PICOCARE removes tattoos in various colors in less time with 1064nm, 532nm, 595nm, an…
Read the full storyThursday, June 15, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Cynosure
Sculpture OK'd for Back, Inner and Outer Thighs
The U.S. Food and Drug Administration (FDA) granted an expanded clearance for Cynosure's SculpSure to treat the back and inner and outer thighs. The SculpSure treatment is already FDA…
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