PMA P090016S050

Device: Belotero Balance (+) Lidocaine
Applicant: Merz North America, Inc.
Product code: LMH
Decision date: 2023-09-27
Generic name: Implant, dermal, for aesthetic use
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.

Current openFDA PMA Record

Device: Belotero Balance (+) Lidocaine
Applicant: Merz North America, Inc.
PMA number: P090016
Supplement: S050
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2023-09-27
Decision code: APPR
Date received: 2023-01-24
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.