Belotero Balance (+) Lidocaine

Primary DI
07640123791220
Brand
Belotero Balance (+) Lidocaine
Company
ANTEIS SA
Model
8705M0S
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).
Published
2021-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LMHImplant, Dermal, For Aesthetic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMHImplant, Dermal, For Aesthetic UseUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640123791220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640123791220076401237912207640123791220

GMDN Terms#

Term, Definition table
TermDefinition
Dermal tissue reconstructive material, microbe-derived, anaestheticA 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 includes a local anaesthetic agent (e.g., lidocaine). 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge27Gauge
Needle Gauge30Gauge
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Freeze
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
482133837
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640123791213Belotero Balance8700M0S2020-10-01
07640123791121Belotero Balance8700M02019-02-01
07640123793309Belotero Balance Lidocaine8718M02025-09-30
07640123793316Belotero Balance Lidocaine8718M0S2025-09-30
07640123791145Belotero Balance (+) Lidocaine 8710M02023-06-01
07640123791152Belotero Balance8706M02023-06-01
07640123791343Belotero Balance (+) Lidocaine 8710M0S2023-06-01
07640123791138Belotero Balance (+) Lidocaine 8705M02021-01-01

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Primary DI, Brand, Company table
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07331689120295Restylane-LQ-Med ABLMH2026-04-29
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