Hyaluronic acid fillers

RHA 4

Teoxane S.A.

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

What it is

Maker: Teoxane S.A.
Category: Hyaluronic acid fillers
Also called: RHA4, Resilient Hyaluronic Acid 4

FDA status

Pathway: FDA-approved medical device (PMA)
Record: P170002 (opens in a new tab)
First approved or cleared: 2017

Research notes

PMA P170002 decision date 2017-10-19. Trademark symbols omitted from quote.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

Injection into the deep skin layer to just under the skin to correct moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds, in adults 22 or older

How it’s sold

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

What the label warns about

Must not be injected into blood vessels.
“RHA 4 must not be injected into blood vessels.”
Source: RHA 2 / RHA 3 / RHA 4 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 P170002, 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 P170002 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.

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

Also cited on this page

fda.gov/consumers/consumer-updates/dermal-filler-dos-and-donts-wrinkles-lips-and-more (opens in a new tab)

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

Treatments that use it

Dermal filler (hyaluronic acid)

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