Lady Parts: Bruce E. Katz, MD, Ushers in Cosmetic Surgery’s Final Frontier
In the November PSP cover story, Bruce E. Katz, MD, talks about how he's helping to usher in cosmetic surgery's final frontier--vaginal rejuvenation.
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Evolus Advances Mid-Face Filler Toward FDA Approval
Evolus has submitted the final module of its PMA application to the FDA for Evolysse Sculpt, an injectable HA gel for mid-face volume restoration.
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POP Recovery Systems and UPMC Plastic Surgery Center Partner to Raise Recovery Standards
The alliance aims to improve pre- and post-operative care and establish new recovery standards.
FDA Approves Revance Daxxify for Frown Lines
Revance Therapeutics received FDA approval for Daxxify to be used as an injectable to improve moderate to severe frown lines in adults.
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FDA Accepts Revance Resubmission for Frown Line Treatment
The FDA has accepted Revance’s BLA resubmission for DaxibotulinumtoxinA for Injection, designed to treat severe glabellar lines.
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Allergan Celebrates 20 Years of Botox
Allergan Aesthetics is celebrating Botox’s 20th anniversary as an FDA-approved product with a cross-country art installation.
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Renuvion Maker Notified of Pending FDA Medical Device Safety Communication
Apyx Medical Corp.—developer of Helium Plasma Technology, which is marketed and sold as Renuvion® in the cosmetic surgery market —has been notified by the U.S. FDA that the agency intends to post a Medical Device Safety Communication related to the Apyx Medical’s Advanced Energy products.
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Revance Resubmits BLA to FDA for DaxibotulinumtoxinA for Injection
Revance Therapeutics Inc, a biotechnology company focused on innovative aesthetic and therapeutic...
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FDA Urges Companies to be ‘Recall Ready’
The U.S. FDA’s final guidance describes the steps companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled product is on the market.
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FDA Advisory Panel Red Lights Integra’s Breast Reconstruction Mesh
An advisory panel on general and plastic surgery voted against recommending FDA approval of Integra LifeSciences’ SurgiMend mesh for the specific indication of breast reconstruction, even though the device has been used in breast reconstruction for more than a decade under a 510(k) clearance, MD+DI reports.
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FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants
The U.S. Food and Drug Administration took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions, according to a news release.
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FDA Approves Spatz3 Adjustable Gastric Balloon
The US Food and Drug Administration (FDA) has approved the Spatz3 Gastric Balloon, an adjustable gastric balloon system, to aid in weight loss for adult patients struggling with obesity, Spatz FGIA Inc announces in a news release.
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ASDSA Applauds FDA for Safety Communication on Needle-less Injector Devices
The American Society for Dermatologic Surgery Association supports the U.S. Food and Drug Administration’s safety communication regarding needle-less devices, such as hyaluron pens (HA pens) for injection of dermal fillers.
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R2 Technologies’ Glacial Rx System Earns Third FDA Indication and Unique Product Code
R2 Technologies Inc, a provider of CryoAesthetic medical devices, announces that its in-office system, Glacial Rx, is now FDA-cleared for general dermabrasion, scar and acne scar revision, and tattoo removal.
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Microneedling Devices: Getting to the Point on Benefits, Risks and Safety
If you are thinking about having a microneedling procedure, the U.S. Food and Drug Administration recommends you choose a health care provider who is specially trained in microneedling.
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The FDA Just Cleared a New Technology That Can Rival a Facelift Without Surgery
Cytrellis just received the green light for the device, which it’s named the ellacor system with Micro-Coring technology, NewBeauty reports.
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Cytrellis Receives FDA Clearance for Ellacor Micro-Coring Technology
Clearance of the Micro-Coring technology provides a new anti-aging aesthetic skin treatment category, designed to provide a faster healing time without burns or scarring.
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FDA Clears Vivace RF Microneedling System at 2MHz Setting
Aesthetics Biomedical announces that the Vivace RF Microneedling device is now cleared for use at both the 1MHz and the 2MHz frequency.
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