Premarket Approval (PMA)

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.

• Device: Belotero Volume (+) Lidocaine
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Merz North America, Inc.; 6501 Six Forks Rd.; Raleigh, NC 27615
• PMA Number: P250020
• Date Received: 06/26/2025
• Decision Date: 05/19/2026
• Product Code: LMH
• Advisory Committee: General & Plastic Surgery
• Clinical Trials: NCT04886232
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for deep (subcutaneous and/or supraperiosteal) injection to improve volume deficit in the mid-face or to correct mid-face contour deficiencies in adults 22 years or older

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Supplements: S003 S001 S002