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5 Recent FDA Approvals, Clearances of Note


FDA approvals in 2020 included Galderma’s Restylane Kysse, Endo Aesthetics QWO for cellulite, and more.

In 2020, Endo Aesthetics announced FDA approval for QWO for cellulite, Galderma introduced the specialty to Restylane Kysse, Allergan, an AbbVie company, received approval for JUVÉDERM® VOLUMA™ XC, MiniTC received clearance for fat grafting, and Soliton announced clearance for its Generation II RAP Device. 

MiniTC Receives FDA Clearance for Fat Grafting

Clearance of the closed-loop device helps to legitimize the growing field of regenerative medicine.

Endo Aesthetics Announces FDA Approval of QWO for Cellulite Treatment

Endo Aesthetics announced the U.S. FDA approval of QWO for the first and only injectable treatment of moderate to severe cellulite of the buttocks in adult women.

Galderma Announces FDA Approval for Restylane Kysse

Adding to its line of HA fillers, Galderma recently announced the FDA approval of Restylane Kysse for lip augmentation and correction of upper perioral rhytids.

Soliton Announces clearance for Generation II RAP Device

Soliton recently announced that the FDA has given their Generation II RAP device special 510(k) premarket notification clearance as an adjunct to lasers for tattoo removal, with a planned commercial launch in mid-2020.

JUVÉDERM® VOLUMA™ XC Approved for Chin Augmentation

Allergan announces the FDA approval of JUVÉDERM® VOLUMA™ XC for use in the chin region to improve the chin profile.

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