Hyaluronic acid fillers
Restylane Refyne
Galderma (PMA applicant: Q-Med AB)
What it is
- Maker
- Galderma (PMA applicant: Q-Med AB)
- Category
- Hyaluronic acid fillers
- Also called
- Refyne
FDA status
- Pathway
- FDA-approved medical device (PMA)
- First approved or cleared
- 2016
Research notes
Original PMA P140029 decision date 2016-12-09. The only P140029 labeling opened was patient information ('About Restylane Refyne'), which did not yield a vascular-injection warning in text search; no clinician label warning is recorded.
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
FDA consumer update: the provider should use properly labeled, sealed vials or pre-filled syringes of FDA-approved filler; do not buy fillers sold directly to the public or use needle-free injection pens. Content current as of 2023-07-07.
fda.gov/consumers/consumer-updates/dermal-filler-dos-and-donts-wrinkles-lips-and-more (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 P140029, 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…
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.
- Name the fillerGet the exact product, not only material class or syringe count.
- 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
- Inspect package identityThe practice should be able to show the sealed product and label before use.
- Verify injectorCheck the named person and applicable state license.
- 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
- FDA PMA database: P140029 (Restylane Refyne, Restylane Defyne) (opens in a new tab)FDA database
- FDA: Dermal Fillers (Soft Tissue Fillers) (opens in a new tab)FDA notice
Also cited on this page
Checked Sep 14, 2026 · Partly confirmed.
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