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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRestylane® Lyft with Lidocaine
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-752-28
PMA NumberP040024
Supplement NumberS142
Date Received01/30/2025
Decision Date11/04/2025
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT05777759
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for Restylane® Lyft with Lidocaine for subcutaneous and/or supraperiosteal implantation for augmentation of the chin region to improve the chin profile in patients over the age of 21 with mild to moderate chin retrusion.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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