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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Vivace Ultra Receives FDA Clearance
Aesthetics Biomedical’s Vivace Ultra microneedling RF device was cleared by the FDA for use in dermatological and surgical procedures.
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Plastic Surgeon Sees Uptick in Male Patients Receiving Breast Reduction Surgery
Female breast reduction surgery has always been a common procedure at Azouz Plastic and Cosmetic Surgery in Dallas, according to founder David Azouz, MD. Now men are joining the ranks, he says, highlighting the influx of gynecomastia surgeries he has performed over the last four decades.
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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Eclipse Launches MicroPen EVO Advanced Microneedling Device
Eclipse announces FDA clearance of its latest medical-grade microneedling device, the MicroPen EVO. Launched in 2020 in Canada, the MicroPen EVO is now available to dermatology and aesthetic practices in the United States.
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Revance Therapeutics Provides Update on DaxibotulinumtoxinA for Injection Pre-Approval Inspection
Revance Therapeutics Inc announces that the FDA plans to initiate its pre-approval inspection of the company’s manufacturing facility for DaxibotulinumtoxinA for Injection by the end of June 2021.
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FDA Clears SkinPen Precision to Treat Neck Wrinkles
The U.S. Food and Drug Administration (FDA) has cleared the SkinPen Precision microneedling device to treat neck wrinkles. This means SkinPen is now cleared to treat both the face and neck, Crown Aesthetics announces.
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MTF Biologics Says FDA Used Old Data to Malign Its Surgical Mesh
A surgical mesh company claims the FDA improperly called one of its products’ safety into question, Medical Design & Outsourcing reports.
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FDA Clears Rapid Acoustic Pulse Technology by Soliton
The RAP technology is designed to harness the power of sound for the treatment of cellulite.
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