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Biostimulators

Radiesse (+)

Merz North America, Inc.

FDA-approved medical device (PMA)Checked Sep 14, 2026 · Read on the pages cited

What it is

Maker
Merz North America, Inc.
Category
Biostimulators
Also called
Radiesse Plus, Radiesse (+) Lidocaine, RADIESSE (+)

FDA status

Pathway
FDA-approved medical device (PMA)
First approved or cleared
Not confirmed — see the research notes

Research notes

S129 (panel track) decision 2021-09-01 expanded Radiesse (+) to the jawline. Both indications listed appear in the S129 instructions for use. The supplement that first approved the lidocaine (+) formulation was not verified, so the first authorization year is not recorded here.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Implantation under the skin (subdermal) to correct moderate to severe facial wrinkles and folds, such as nasolabial folds
  • Deep injection (under the skin and/or on the bone surface) to improve moderate to severe loss of jawline contour, in adults over 21 (approved 2021, P050052/S129)

How it’s sold

How it’s sold isn’t recorded for this entry.

What the label warns about

Checking it’s the real thing

  • FDA advises not buying dermal fillers online (they could be counterfeit or not approved for U.S. use) and urges providers to inspect filler packages for authenticity. Page content current as of 2023-07-06.

    FDA: Dermal Fillers (Soft Tissue Fillers) (opens in a new tab) · publication date not recorded · checked Sep 14, 2026

Ask in the room

“What’s the brand name printed on the box, vial or device panel — and may I see it?”

Recalls and enforcement

FDA recall and enforcement records filed under P050052/S129, read live from openFDA. A recall usually covers particular models or lots, not every unit ever made.

Searching FDA recall and enforcement records by this product’s FDA number…

Look up P050052/S129 and a number from the box

Check it yourself

Dermal filler proof ladder: The service uses a soft-tissue filler or sells an outcome such as facial balancing. Work down in order — each step needs the one before it.

  1. Name the fillerGet the exact product, not only material class or syringe count.
  2. Match the reviewed useCompare the product and proposed location with the FDA filler record.FDA-Approved Dermal Fillers (opens in a new tab) · U.S. Food & Drug Administration
  3. Inspect package identityThe practice should be able to show the sealed product and label before use.
  4. Verify injectorCheck the named person and applicable state license.
  5. Name complication ownershipAsk who can be reached after hours and what the written escalation route is.

Worth knowing

What an FDA record can and can’t tell you

FDA records show what was authorized, for what, and when.

They can’t show that the product in the room is authentic, in date, stored properly, or being used for its authorized purpose. Those are questions for the room.

Sources

  1. FDA PMA database: P050052/S129 (Radiesse (+) Injectable Implant) (opens in a new tab)FDA database
  2. RADIESSE (+) Lidocaine instructions for use (FDA PMA document) (opens in a new tab)Label
  3. FDA: Dermal Fillers (Soft Tissue Fillers) (opens in a new tab)FDA notice

Checked Sep 14, 2026 · Read on the pages cited.

Treatments that use it

No treatment guide lists this product yet.

Product identity

Told a name? Shown a box?

Type what was said or printed, see whether it matches a registry entry, and note what you saw in your booking file.

Check a name