Belotero Balance

Primary DI
07640123791121
Brand
Belotero Balance
Company
ANTEIS SA
Model
8700M0
Device description
Belotero Balance is a hyaluronic-acid based dermal filler approved 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 a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.
Published
2019-02-01
Public version status
Update
Distribution status
Not 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
P090016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P090016000BELOTERO BALANCEMerz North America, Inc.2011-11-14LMH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640123791121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640123791121076401237911217640123791121

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 Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-972-4588myMerzSolutions@merz.com

Regulatory Flags#

DUNS number
482133837
Device count
1
Kit
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
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
07640123791220Belotero Balance (+) Lidocaine 8705M0S2021-01-01

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