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Regulatory Approvals

Regulatory Approvals

FDA Accepts Label Update for Plasma IQ™, the First FDA-Cleared Handheld Plasma Energy Device

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Suneva Medical, Inc. ("Suneva" or the "Company"), an innovative medical technology company using regenerative medicine to change the standard of care in aesthetic...
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Regulatory Approvals

U.S. FDA Approves New MENTOR® MemoryGel BOOST™ Breast Implant

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Implant provides the natural feel patients desire with increased form stability to shape the breast Recent study shows patients...
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Regulatory Approvals

Sculptra Gets New Label

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FDA approves higher dilution, immediate reconstitution, and more. A new FDA-approved label for Sculptra® (injectable poly-L-lactic acid (PLLA)) from Galderma...
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Regulatory Approvals

Squid Healthcare Announces FDA 510(k) Submission for EyeMask MD

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The masks were developed for the management of 1st and 2nd degree partial thickness burns, donor sites and traumatic and surgical wounds.
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Regulatory Approvals

FDA Clears Sofwave for Eyebrows, Sub-Mental, and Neck Facial Areas

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The Sofwave system is also cleared for improving facial lines and wrinkles. Sofwave is now U.S. Food and Drug...
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Regulatory Approvals

Hugel America Announces FDA Acceptance of BLA for LetibotulinumtoxinA to Treat Glabellar Lines

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Hugel America, Inc., a growth focused joint venture between aesthetic market-leading partners Hugel Inc., and Croma-Pharma GmbH, today announced that the Biologics...
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Regulatory Approvals

Venus Concept Receives FDA 510(k) Clearance for the Venus Freedom™

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Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, announced that it has received 510(k)...
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Regulatory Approvals

Squid Healthcare Announces FDA 510(k) Submission for EyeMask MD®

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Squid Healthcare, Inc., a medical aesthetic company innovating periocular wellness for post-surgical and non-surgical procedures, announced it has submitted a 510(k) premarket...
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Regulatory Approvals

Anticipated Canadian filler Revanesse arrives in the UK

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A new HA dermal filler product is to officially launch onto the UK market in October. FDA-approved Revanesse, from...
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Regulatory Approvals

Ellacor System Cleared by FDA

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Cytrellis announced that the FDA has cleared the ellacor system to the treatment of moderate to severe wrinkles. Cytrellis...
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Regulatory Approvals

Alma Hybrid Laser Receives FDA 510(k) Clearance

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Alma announces the FDA clearance of its Alma Hybrid combination platform, which includes an ablative 10,600 nm (CO2) laser and nonablative 1570...
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Regulatory Approvals

Restylane Contour Receives FDA Approval

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Galderma receives Restylane Contour FDA approval for cheek augmentation and correction of midface contour deficiencies. Galderma today announced the FDA approval...
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BTL Aesthetics Celebrates Third Annual National EMSCULPT Week

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A nationwide competition is underway for Emsculpt and Emsculpt NEO providers that will give back to a charity focused on strengthening the...
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Hamilton Fraser’s ABC conference to take place

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The Aesthetics Business Conference (ABC) organised by Hamilton Fraser Cosmetic Insurance will take place in October. The conference aims...
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4T Medical offers combined non-surgical facelift course

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Aesthetic supplier and training provider 4T Medical has introduced a combined dermal filler and thread course. According to the...
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Elevai Labs Appoints New Chief Marketing and Brand Advisor

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Elevai Labs has announced the appointment of industry expert Brenda Buechler as its chief marketing and brand advisor. ELEVAI is a science-based, data-driven...
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EDITOR PICKS

BTL Aesthetics Celebrates Third Annual National EMSCULPT Week

Events 0
A nationwide competition is underway for Emsculpt and Emsculpt NEO providers that will give back to a charity focused on strengthening the...
Read more

Hamilton Fraser’s ABC conference to take place

Innovation 0
The Aesthetics Business Conference (ABC) organised by Hamilton Fraser Cosmetic Insurance will take place in October. The conference aims...
Read more

4T Medical offers combined non-surgical facelift course

Events 0
Aesthetic supplier and training provider 4T Medical has introduced a combined dermal filler and thread course. According to the...
Read more

POPULAR POSTS

BTL Aesthetics Celebrates Third Annual National EMSCULPT Week

Events 0
A nationwide competition is underway for Emsculpt and Emsculpt NEO providers that will give back to a charity focused on strengthening the...
Read more

Hamilton Fraser’s ABC conference to take place

Innovation 0
The Aesthetics Business Conference (ABC) organised by Hamilton Fraser Cosmetic Insurance will take place in October. The conference aims...
Read more

4T Medical offers combined non-surgical facelift course

Events 0
Aesthetic supplier and training provider 4T Medical has introduced a combined dermal filler and thread course. According to the...
Read more

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