Belotero Balance Lidocaine

Primary DI
07640123793316
Brand
Belotero Balance Lidocaine
Company
ANTEIS SA
Model
8718M0S
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
2025-09-30
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

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P090016028
P090016062

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P090016028BELOTERO BALANCEMerz North America, Inc.2011-11-14LMH
P090016062BELOTERO BALANCEMerz North America, Inc.2011-11-14LMH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640123793316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640123793316076401237933167640123793316

GMDN Terms#

Term, Definition table
TermDefinition
Dermal tissue reconstructive material, microbe-derivedA 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.

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 Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-469-6379mymerzsolutions@merz.com

Regulatory Flags#

DUNS number
482133837
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
07640123791145Belotero Balance (+) Lidocaine 8710M02023-06-01
07640123791152Belotero Balance8706M02023-06-01
07640123791343Belotero Balance (+) Lidocaine 8710M0S2023-06-01
07640123791138Belotero Balance (+) Lidocaine 8705M02021-01-01
07640123791220Belotero Balance (+) Lidocaine 8705M0S2021-01-01

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Primary DI, Brand, Company table
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07331689120325Restylane EyelightQ-Med ABLMH2026-04-30
07331689120332Restylane EyelightQ-Med ABLMH2026-04-30
07331689120288Restylane-LQ-Med ABLMH2026-04-29
07331689120295Restylane-LQ-Med ABLMH2026-04-29
08437027710117SCULPTRASAIMA GLOBAL FARMA S.L.LMH2026-02-19
08437027710100SCULPTRASAIMA GLOBAL FARMA S.L.LMH2026-02-19
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00362032907017saypha MagIQObagi Cosmeceuticals LLCLMH2025-11-27
00362032907024saypha MagIQ SAMPLEObagi Cosmeceuticals LLCLMH2025-11-27
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08437027710063RESTYLANE DEFYNESAIMA GLOBAL FARMA S.L.LMH2025-06-30
08437027710070RESTYLANE KYSSESAIMA GLOBAL FARMA S.L.LMH2025-06-30
08437027710087RESTYLANE LYFT WITH LIDOCAINESAIMA GLOBAL FARMA S.L.LMH2025-06-30
08437027710094RESTYLANE REFYNESAIMA GLOBAL FARMA S.L.LMH2025-06-30
07640173236177RHA® 3 MepiTeoxane SALMH2025-05-01
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03760172161264EVOLYSSE FORMSYMATESELMH2025-02-19
03760172161271EVOLYSSE SMOOTHSYMATESELMH2025-02-19
03760172161288EVOLYSSE FORMSYMATESELMH2025-02-19
03760172161295EVOLYSSE FORMSYMATESELMH2025-02-19
03760172161301EVOLYSSE SMOOTHSYMATESELMH2025-02-19
03760172161318EVOLYSSE SMOOTHSYMATESELMH2025-02-19
03770034301103RadiesseUNIVERDERMLMH2024-12-02
03770034301097RadiesseUNIVERDERMLMH2024-12-02