FDA UDI
In Commercial Distribution
🇺🇸 United States
Belotero Balance Lidocaine
DI: 07640123793309
·
Model: 8718M0
·
ANTEIS SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Belotero Balance Lidocaine
- Primary DI
- 07640123793309
- Version / Model
- 8718M0
- Company Name
- ANTEIS SA
- Labeler DUNS
- 482133837
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-30
- Public Version
- 2
- Public Version Date
- 2026-02-11
- Public Version Status
- Update
- Public Device Record Key
- 25824962-3573-4b6e-8c2a-8ad383de8b4f
Device Description
Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction and treatment of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, and for volume augmentation for the improvement of the infraorbital hollow in adults over the age of 21. The device is kitted in a blister pack containing: (1) a 1mL pre-filled syringe of sterile gel, and (2) two sterile needles (27G x 1/2, 30G x 1/2).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LMH | Implant, Dermal, For Aesthetic Use | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59131 | Dermal tissue reconstructive material, microbe-derived | A sterile, bioabsorbable, bacteria-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it does not include a local anaesthetic agent. It typically includes bacterial hyaluronic acid (HA) as the principal constituent and is typically preloaded in a disposable syringe; disposable needle(s)/cannula(e) dedicated to injection may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640123793309 | GS1 |
Customer Contacts
- Phone
- 1-844-469-6379
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P090016 | 028 |
| P090016 | 062 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Milliliter | |
| Needle Gauge | 27 | Gauge | |
| Needle Gauge | 30 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- DO NOT FREEZE
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius