Latest News - FDA Approval/Clearance

Monday, June 24, 2019 | FDA Approval/Clearance, Product Launches and Updates, Allergan

FDA Approves CoolTone Device from Allergan

The FDA has cleared Allergan plc's CoolTone device for improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone is also indicated fo…

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Tuesday, April 30, 2019 | FDA Approval/Clearance, Personnel/Company News, PracticalDermatology.com, Galderma

Galderma's Dysport Celebrates 10 Years Since FDA Approval

Galderma Laboratories’ Dysport (abobotulinumtoxinA) is ringing in its 10th birthday. To celebrate this milestone, Galderma is offering double points for Dysport aesthetic treatments registere…

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Tuesday, February 12, 2019 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, American Academy of Dermatology, American Society for Laser Medicine and Surgery

Laseroptek’s PicoLO Scores FDA 510(k) Marketing Clearance

Laseroptek’s PicoLO picosecond Nd:YAG laser is now U.S. Food and Drug Administration-cleared for marketing in dermatology and general and plastic surgery. According to the company, PicoLO gen…

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Tuesday, February 12, 2019 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates

FDA Clears Lutronic Genius Platform for RF Microneedling

Lutronic has received FDA clearance of the Lutronic Genius™ platform for radiofrequency microneedling. The company says the device transmits energy more precisely into the skin.   …

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Saturday, February 02, 2019 | FDA Approval/Clearance, Personnel/Company News, PracticalDermatology.com, Evolus

Evolus: Jeuveau FDA Cleared for Aesthetic Injection

The FDA has approved Jeuveau™ (prabotulinumtoxinA-xvfs), the lead product from Evolus, Inc., for the temporary improvement in the appearance of moderate to severe glabellar lines associated with…

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Wednesday, December 19, 2018 | FDA Approval/Clearance, Product Launches and Updates, Allergan

Allergan Withdraws Sales of Textured Breast Implants, Tissue Expanders in Europe

Allergan is suspending sales of textured breast implants and tissue expanders and is withdrawing any remaining supply in European markets. The withdrawal decision follows a compulsory recall reques…

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Thursday, December 13, 2018 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Cynosure

Hologic’s Cynosure Division Rolls Out TempSure Surgical RF Technology in North America

Hologic, Inc.’s Cynosure division is launching the U.S. Food and Drug Administration (FDA)-cleared TempSure Surgical RF technology in North America.  This is a new offer…

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Monday, November 05, 2018 | FDA Approval/Clearance, PracticalDermatology.com, Research and Publications, Galderma

FDA Green Light’s Galderma’s Restylane Lyft for Midface Injection Via Cannula

The U.S. Food and Drug Administration (FDA) has approved the use of Galderma’s Restylane Lyft with a small, blunt-tip cannula for cheek augmentation and the correction of age-related m…

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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…

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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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