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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBelotero® Intense (+) Lidocaine
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
6501 Six Forks Rd.
Raleigh, NC 27615
PMA NumberP250016
Date Received06/17/2025
Decision Date07/09/2026
Product Code LMH 
Docket Number 26M-7708
Notice Date 07/09/2026
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT05773066
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Belotero® Intense (+) Lidocaine is indicated for submucosal and/or subcutaneous implantation for lip augmentation in adults over the age of 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S004 
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