Duns Number:482133837
Device Description: Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injec Belotero Balance (+) Lidocaine 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 (+) Lidocaine gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2, 30G x 1/2), and (3) two patient record labels
Catalog Number
-
Brand Name
Belotero Balance (+) Lidocaine
Version/Model Number
8705M0S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LMH
Product Code Name
Implant, Dermal, For Aesthetic Use
Public Device Record Key
336d526c-2e56-43bf-b960-2857f4ef4d01
Public Version Date
January 11, 2021
Public Version Number
1
DI Record Publish Date
January 01, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 4 |