Latest News - FDA Approval/Clearance

Thursday, October 12, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Galderma

Galderma's Restylane Silk Approved for Injection via Cannula for Lip Augmentation

The FDA approved the use of a small blunt tip cannula with Restylane Silk for lip augmentation. Galderma's Restylane Silk was the first FDA-approved hyaluronic acid (HA) dermal filler specifically…

Read the full story

Wednesday, October 04, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Solta, Valeant NJ

FDA Clears Thermage’s FLX System for Smoothing Skin

The U.S. Food and Drug Administration (FDA) granted 510(K) clearance to Solta Medical’s new Thermage FLXTM System for smoothing skin on the face, eyes, and body. The Thermage FLX fe…

Read the full story

Wednesday, October 04, 2017 | FDA Approval/Clearance, Product Launches and Updates, Johnson & Johnson

MENTOR’s MemoryGel Xtra Breast Implants Hit US

Mentor Worldwide LLC’s MemoryGel® Xtra Breast Implants are now available in in the United States. MENTOR MemoryGel Xtra is being showcased at the 2017 Plastic Surgery Meeti…

Read the full story

Tuesday, October 03, 2017 | FDA Approval/Clearance, Allergan

FDA Approves Botox Cosmetic for Moderate to Severe Forehead Lines

The FDA approved Allergan plc's Botox Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity …

Read the full story

Wednesday, September 27, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Cynosure

Sculpture OK'd as Double Chin Treatment

Cynosure's SculpSure®  is now cleared for submental fat reduction. The U.S. Food and Drug Administration (FDA) granted an expanded FDA 510(k) clearance for this area, Hologic, Inc. rep…

Read the full story

Wednesday, September 27, 2017 | FDA Approval/Clearance, PracticalDermatology.com

FDA Clears Fotona's StarWalker MaQX Ultra Performance Q-Switched System

The FDA has cleared Fotona's StarWalker MaQX Q-Switched laser system for treating tattoos, pigmented and vascular lesions, acne and scar revision, and permanent hair reduction. The Verde 532 mode …

Read the full story

Tuesday, September 26, 2017 | FDA Approval/Clearance

Federal Judge Orders Flawless Beauty to Stop Distributing Unapproved Drugs, Recall Certain Products

A federal judge ordered a New Jersey company that sold injectable skin whitening and other beauty products to stop selling and recall some of its products because they are unapproved new drugs that ma…

Read the full story

Friday, June 23, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Product Launches and Updates, Tattoo

There’s a New Pico in Town: Wontech’s Picocare Scores FDA Nod

The U.S. Food and Drug Administration (FDA) cleared WONTECH’s picosecond laser device for tattoo removal. PICOCARE removes tattoos in various colors in less time with 1064nm, 532nm, 595nm, an…

Read the full story

Thursday, June 15, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Cynosure

Sculpture OK'd for Back, Inner and Outer Thighs

The U.S. Food and Drug Administration (FDA) granted an expanded clearance for Cynosure's SculpSure to treat the back and inner and outer thighs. The SculpSure treatment is already FDA…

Read the full story

Wednesday, May 03, 2017 | FDA Approval/Clearance

Millennium Medical Technologies Receives FDA Clearance for Reusable Fat Collection, Grafting System

Millennium Medical Technologies has become the first in the nation to receive FDA clearance for a reusable fat collection and transfer system used in plastic or reconstructive surgery and regener…

Read the full story

Monday, March 20, 2017 | FDA Approval/Clearance, PracticalDermatology.com, Allergan

Juvéderm Vollure XC FDA Approved for Correction of Facial Wrinkles and Folds

The FDA has approved Allergan plc's Juvéderm Vollure XC for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over the age of 21. In the US piv…

Read the full story

Tuesday, January 03, 2017 | FDA Approval/Clearance, Product Launches and Updates, Allergan

FDA Approves Allergan's NATRELLE INSPIRA SoftTouch Breast Implants

The FDA granted Allergan plc approval to market Natrelle Inspira SoftTouch breast implants, offering women undergoing breast reconstruction, augmentation, or revision surgery a new medium firmness gel…

Read the full story

Monday, December 12, 2016 | FDA Approval/Clearance, PracticalDermatology.com, Galderma

FDA Approves Restylane Refyne and Restylane Defyne Dermal Fillers for “Laugh Lines”

The FDA has approved two new Galderma products for the treatment of nasolabial folds (NLF) or “laugh lines,” in patients over the age of 21. Restylane Refyne was approved for the treatment…

Read the full story

Tuesday, November 08, 2016 | FDA Approval/Clearance, PracticalDermatology.com

Syneron Candela's Profound SubQ FDA Approved to Improve Cellulite

Syneron Candela  received FDA 510(k) clearance for Profound when using the SubQ handpiece and cartridge to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III, as su…

Read the full story