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Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal FillerP090016

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Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler is a Hyaluronic acid filler product, registered by Merz North America, Inc.. Linked registrations: US P090016. First approved in US on 2011-11-14 (P090016). Data as of 2026-10-19.

  • Regulatory classHyaluronic acid filler · class not determined
  • HolderMerz North America, Inc.
  • JurisdictionsUS
  • Updated2026-10-19 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler

Product
Regulatory class
Not determined (no verified registration linked)Could not verify
Category
Hyaluronic acid filler
US · FDA PMA
P090016
Name on registration
BELOTERO BALANCE
Registrant
Merz North America, Inc.
First approval
2011-11-14
This certificate issued
2011-11-14
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

No data yet

Registration timeline

  1. US

    P090016 first approved

  2. US

    P090016 · P090016/S062

    Real-Time Process｜Change Design/Components/Specifications/Material｜Approval for the qualification of the alternate secondary packaging desig…

  3. US

    P090016 · P090016/S064

    Real-Time Process｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for extending the shelf life for Belotero Balance…

  4. US

    P090016 · P090016/S065

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval of an alternate, semi-automated secondary packaging line f…

  5. US

    P090016 · P090016/S066

    Normal 180 Day Track｜Change Design/Components/Specifications/Material｜approval for a change to the release and shelf-life specifications for…

  6. US

    P090016 · P090016/S068

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜modifications to the assay for determining the concentration of lid…

  7. US

    P090016 · P090016/S067

    Normal 180 Day Track｜Change Design/Components/Specifications/Material｜approval for the use of sodium hyaluronate raw material manufactured a…

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record.

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Recent changes

5
  • P090016: Normal 180 Day Track｜Change Design/Components/Specifications/Material｜approval f…2026-05-03
  • P090016: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜modific…2025-10-24
  • P090016: Normal 180 Day Track｜Change Design/Components/Specifications/Material｜approval f…2025-10-10
  • P090016: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2025-01-15
  • P090016: Real-Time Process｜Labeling Change - Indications/instructions/shelf life/tradenam…2025-01-08

Sources

1