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Belotero Balance

FDA UDI

Class III (US FDA UDI)

by Anteis Sa

Identity

Trade Name
Belotero Balance FDA UDI
Generic Name
Dermal tissue reconstructive material, microbe-derived FDA UDI
Device Name
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. FDA UDI
Model / Reference
8700M0 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
07640123791121 FDA UDI
PMA Number
P090016 FDA UDI
FDA Product Code
LMH FDA UDI
GMDN Term
Dermal tissue reconstructive material, microbe-derived FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 1 Milliliter FDA UDI
Needle Gauge — 27 Gauge FDA UDI
Needle Gauge — 30 Gauge FDA UDI

Category: Dermal tissue reconstructive material, microbe-derived

Belotero Balance by Anteis Sa — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermal tissue reconstructive material, microbe-derived.

Cleared under the same submission

P090016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anteis Sa

Sources (1)

  • FDA UDI 42e9cb92-702a-4131-9893-971a7fd92cbd 37 fields · synced May 30, 2026