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Biostimulators

Radiesse

Merz North America, Inc.

FDA-approved medical device (PMA)Checked Sep 14, 2026 · Partly confirmed

What it is

Maker
Merz North America, Inc.
Category
Biostimulators
Also called
calcium hydroxylapatite, CaHA, RADIESSE

FDA status

Pathway
FDA-approved medical device (PMA)
First approved or cleared
2006

Research notes

PMA decision date 2006-12-22 (applicant Merz North America, Inc.). Other Radiesse indications added by supplements (e.g., hands) were not verified. No label for original Radiesse was opened; the Radiesse (+) label (see radiesse-plus) warns that introduction into the vasculature may lead to embolization, occlusion, ischemia or infarction.

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

How it’s sold

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

What the label warns about

No label warning is recorded here. That isn’t the same as the label having none — the research notes and sources say what was opened.

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, 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 and a number from the box

What changed at the source

Dated FDA records that concern Radiesse, newest first. A record says what happened at the source; it is not a finding about any clinic's stock.

  1. Approval or clearance ·

    FDA approved Radiesse, diluted 1:2 with saline, for décolleté wrinkles

    U.S. Food & Drug Administration · PMA P050052/S162

    A PMA supplement approved on March 31, 2026 expanded Radiesse's indications to subdermal implantation of Radiesse diluted 1:2 with 0.9% sterile saline for correcting décolleté wrinkles in patients 22 and older. Merz announced it on April 8, 2026.

    What this source establishes
    That Radiesse diluted 1:2 with saline, placed in the décolleté for adults 22 and older, is within the approved labeling.
    What it does not establish
    That undiluted Radiesse, another dilution or another area is approved for the décolleté, or who a state allows to inject it.

    The official record (opens in a new tab) · Merz Aesthetics’s announcement (opens in a new tab) (the maker’s words, not the record) · checked Sep 25, 2026

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 (RADIESSE INJECTABLE IMPLANT) (opens in a new tab)FDA database
  2. FDA: Dermal Fillers (Soft Tissue Fillers) (opens in a new tab)FDA notice

Checked Sep 14, 2026 · Partly confirmed.

Treatments that use it

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