Latest News - FDA Approval/Clearance

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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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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