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Belotero® Intense (+) LidocaineP250016

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Belotero® Intense (+) Lidocaine is a Hyaluronic acid filler product, registered by Merz North America, Inc.. Linked registrations: US P250016. First approved in US on 2026-07-09 (P250016). Data as of 2026-11-03.

  • Regulatory classHyaluronic acid filler · class not determined
  • HolderMerz North America, Inc.
  • JurisdictionsUS
  • Updated2026-11-03 · v1

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

Registration and basics

Belotero® Intense (+) Lidocaine

Product
Regulatory class
Not determined (no verified registration linked)Could not verify
Category
Hyaluronic acid filler
US · FDA PMA
P250016
Registrant
Merz North America, Inc.
First approval
2026-07-09
This certificate issued
2026-07-09
Checked against official page
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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

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Registration timeline

  1. US

    P250016 first approved

  2. US

    P250016 · P250016/S002

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approval for a new automated washer at Site Lonay used for cleaning…

  3. US

    P250016 · P250016/S001

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for modifications to the assay for determining the concent…

  4. US

    P250016 · P250016/S004

    Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜approval of the protocol for the post-approval study (PAS) referenced above. Th…

  5. US

    P250016 · P250016/S006

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for modifications to the manual cleaning process for utens…

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

4
  • P250016: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2026-10-21
  • P250016: Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜approval of the pro…2026-08-31
  • P250016: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2026-08-05
  • P250016: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approva…2026-07-31

Sources

1