Hyaluronic acid fillers
Restylane Kysse
Galderma (PMA applicant: Q-Med AB)
What it is
- Maker
- Galderma (PMA applicant: Q-Med AB)
- Category
- Hyaluronic acid fillers
- Also called
- Kysse
FDA status
- Pathway
- FDA-approved medical device (PMA)
- First approved or cleared
- 2020
Research notes
S021 (panel track) decision date 2020-03-26; a labeling/indication/trade-name supplement to P140029 (the Refyne/Defyne PMA). Syringe volume not confirmed.
How it’s sold
How it’s sold isn’t recorded for this entry.
What the label warns about
Filler entering a blood vessel can block it and cause tissue injury; the label says not to use it in vessel-rich areas.
“Introduction of Restylane Kysse into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.”
Source: Restylane Kysse labeling (FDA PMA document) (opens in a new tab)
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/S021, 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/S021 (Restylane Kysse) (opens in a new tab)FDA database
- Restylane Kysse labeling (FDA PMA document) (opens in a new tab)Label
- FDA: Dermal Fillers (Soft Tissue Fillers) (opens in a new tab)FDA notice
Also cited on this page
Checked Sep 14, 2026 · Read on the pages cited.
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