FDA.reportPublic FDA data

Belotero Intense (+) Lidocaine

Primary DI
07640123793330
Brand
Belotero Intense (+) Lidocaine
Company
ANTEIS SA
Model
8719M0S
Device description
Belotero Intense (+) Lidocaine dermal filler 1mL, 2 x 27G.
Published
2026-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHMSystem, Thermographic, Liquid Crystal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHMSystem, Thermographic, Liquid CrystalObstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P250016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250016000Belotero® Intense (+) LidocaineMerz North America, Inc.2026-07-09LMH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640123793330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640123793330076401237933307640123793330

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge0
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Freeze
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
482133837
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640123793323Belotero Intense (+) Lidocaine8719M02026-11-02
07640123791138Belotero Balance (+) Lidocaine8705M02021-01-01
07640123791220Belotero Balance (+) Lidocaine8705M0S2021-01-01
07640123792982Belotero Volume (+) Lidocaine8716M02026-08-08
07640123792999Belotero Volume (+) Lidocaine8716M0S2026-08-08
07640123793309Belotero Balance Lidocaine8718M02025-09-30
07640123793316Belotero Balance Lidocaine8718M0S2025-09-30
07640123791145Belotero Balance (+) Lidocaine8710M02023-06-01
07640123791152Belotero Balance8706M02023-06-01
07640123791343Belotero Balance (+) Lidocaine8710M0S2023-06-01
07640123791213Belotero Balance8700M0S2020-10-01
07640123791121Belotero Balance8700M02019-02-01