Premarket Approval (PMA)

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.

• Device: Belotero Balance (+) Lidocaine
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: MERZ NORTH AMERICA, INC; 4133 COURTNEY ROAD; SUITE 10; FRANKSVILLE, WI 53126
• PMA Number: P090016
• Supplement Number: S050
• Date Received: 01/24/2023
• Decision Date: 09/27/2023
• Product Code: LMH
• Advisory Committee: General & Plastic Surgery
• Clinical Trials: NCT03777917
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for Belotero Balance(R) (+) for Expanding the Indications to Include Volume Augmentation for the Improvement of the Infraorbital Hollow in Adults Over the Age of 21. This device is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is also indicated for volume augmentation for the improvement of the infraorbital hollow in adults over the age of 21.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2