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Belotero VolumeBelotero

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Belotero Volume is a Hyaluronic acid filler product, registered by Merz North America, Inc.. Linked registrations: US P250020, UK PARD-966784. First approved in US on 2026-05-19 (P250020). Data as of 2026-11-09.

  • Regulatory classHyaluronic acid filler · class not determined
  • HolderMerz North America, Inc.
  • JurisdictionsUS · UK
  • Updated2026-11-09 · v1

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

Registration and basics

Belotero Volume

Product
Regulatory class
Not determined (no verified registration linked)Could not verify
Category
Hyaluronic acid filler
US · FDA PMA
P250020 (link pending review)
UK · MHRA device registration (not an approval)
PARD-966784 (link pending review)
Name on registration
Belotero Volume (+) Lidocaine
Registrant
Merz North America, Inc.
First approval
2026-05-19
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.Registrant and dates are from P250020; 2 registrations linked.This product record is still pending review.

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. UK

    PARD-966784 registered

  2. US

    P250020 first approved

  3. US

    P250020 · P250020/S001

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for requalification of the cleanroom and controlled areas …

  4. US

    P250020 · P250020/S003

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

  5. US

    P250020 · P250020/S002

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜qualification of an alternative grade of disodium phosphate (salt) …

  6. US

    P250020 · P250020/S005

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for requalification of the cleanroom and controlled manufa…

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. Dates on non-Chinese registrations keep the source's wording: UK devices show the registration date (MHRA does not approve them), Australia the ARTG start date, FDA devices the decision date.

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Recent changes

5
  • P250020: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2026-09-10
  • P250020: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜qualifi…2026-06-25
  • P250020: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜modific…2026-06-23
  • P250020: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2026-06-17
  • PARD-966784: registered2021-04-29

Sources

2