PMA P250016
- Device
- Belotero® Intense (+) Lidocaine
- Applicant
- Merz North America, Inc.
- PMA number
- P250016
- Product code
- LMH
- Decision date
- 2026-07-09
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Belotero® Intense (+) Lidocaine is indicated for submucosal and/or subcutaneous implantation for lip augmentation in adults over the age of 21.
Current openFDA PMA Record#
- Device
- Belotero® Intense (+) Lidocaine
- Applicant
- Merz North America, Inc.
- PMA number
- P250016
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-07-09
- Decision code
- APPR
- Date received
- 2025-06-17
- Approval order statement
- Belotero® Intense (+) Lidocaine is indicated for submucosal and/or subcutaneous implantation for lip augmentation in adults over the age of 21.