Belotero Balance (+) Lidocaine
FDA premarket approval P090016/S050 · decided 2023-09-27
Approval details
- PMA number
- P090016
- Supplement
- S050
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Belotero Balance (+) Lidocaine
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2023-01-24
- Decision date
- 2023-09-27
- Days to decision
- 246 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |