Revofil has no FDA approval for use in the United States. Juvederm does. That is the comparison, and it is not a close one. A search of the FDA's device approval database returns no record under the Revofil name.
Dermal fillers are Class III devices in the US, and there is no lighter route available for them. They go through premarket approval, which requires a clinical trial supporting a specific, named use in a specific part of the face. Juvederm's seven products sit under two such approvals, granted in 2006 and 2013. Revofil sits under none.
Products sold under the Revofil name here arrive through online resellers rather than an approved supply chain. The name belongs to Caregen, a South Korean company. FDA's consumer guidance on this is blunt: do not buy dermal fillers sold directly to the public, approved fillers are prescription-only, and products sold that way "may be fake, contaminated, or not approved for use in the U.S."
In practical terms, a product with no US approval should not be being injected in the US. This page does not describe how Revofil performs, how long it lasts or what it is made of, because none of that can be checked against a US regulatory record. Anything you read that does describe those things is not verifiable.
Fillers are Class III devices, so there is no lesser clearance route a product could have taken instead.
Each individual product was added by a supplement that FDA reviewed separately.
There is no US indication because there was no US application to grant one.
Folds, lips, lines around the mouth, cheeks, chin, temples, jawline definition, the under-eye hollow, and skin smoothness of the cheeks and neck — each belonging to a specific product rather than to the brand.
FDA publishes a summary of safety and effectiveness data for every approved filler. There is none for Revofil, because no application was reviewed. Figures quoted for it cannot be traced to a US regulatory record.
Voluma XC was followed to 24 months, Vollure XC to 18, Volux XC to 12, Ultra XC to 12 months in lips and 24 weeks in folds, and Skinvive to 6 months.
FDA warns the public not to buy dermal fillers sold directly to consumers.
FDA states that approved dermal fillers are indicated for prescription use only.
In one hospital series of 31 people treated for filler complications, over half the products involved were uncertified or of unknown origin, and the most common problems were biofilm and chronic immune reactions.
Juvederm gels were among the most resistant tested in one laboratory comparison, needing 300 units to break down within an hour.
It does not mean FDA looked at Revofil and rejected it. It means no approval application appears in the record at all.
For most product categories that would be a technicality. For dermal fillers it is not, because of how they are regulated. A filler cannot be sold in the US on the basis of resembling an existing product. It has to go through premarket approval with its own clinical evidence for its own named use. That is why the approved products have such specific indications — cheeks, chin, temples, jawline — rather than a general licence to be injected anywhere.
So when a product has no approval, three things follow. There is no FDA-reviewed evidence that it works. There is no FDA-reviewed evidence about its safety profile. And there is no approved labeling telling an injector where and how deep to place it.
You are entitled to see what is being put in your face. FDA's own guidance tells patients to "know the type of product to be injected" and to "request and read the patient labeling information on FDA-approved injectable dermal fillers".
Reasonable questions: what is the product's name and manufacturer, is it FDA-approved, which approval number, and what area is that approval for. A clinic using an approved product will answer all four without hesitation. If the answer to the second question is no, the honest follow-up is why an unapproved product is being used when approved alternatives exist for essentially every facial area.
The clinical reason this matters is not abstract. In a hospital dermatology series of 31 people treated for filler complications, injections had been given by cosmeticians, non-medical practitioners or people of unknown qualification, and over half the products involved were uncertified or of unknown origin. That is a picture of who ends up in hospital rather than a rate — but the pattern is consistent.
Do not panic, and do not go looking for a way to remove it on your own.
Tell a licensed dermatologist or plastic surgeon exactly what you had, when, and where. Bring the box or any paperwork if you have it. If the product was hyaluronic acid, hyaluronidase may be an option, though that use is off-label in the US and the dose depends on the product. If it was not hyaluronic acid, or nobody can establish what it was, hyaluronidase may do nothing — the enzyme works on hyaluronic acid and on nothing else.
Ultrasound is now routinely used to look at filler in the skin and to tell a nodule from an infection from a blocked vessel. That is worth asking about.
Go to an emergency department or call 911 if any of these happen during or after a filler injection:
Sudden change or loss of vision in one or both eyes
Pain that is far worse than the procedure should reasonably cause
Skin that goes white or pale in a patch, then turns dusky, grey or mottled
Weakness on one side, a drooping face, slurred speech or confusion
These are the signs of filler entering a blood vessel. Published guidance treats a suspected eye event as a same-hour emergency and a suspected skin event as a same-day one. One caution about pain: in a survey of 52 experienced injectors, pain was mild or absent in 47% of the intravascular events they reported. Pain is not a reliable alarm, and its absence is not reassurance.
Swelling is still growing after the first few days instead of settling
A lump has not softened
Redness is spreading outward from an injection site
Tenderness, swelling or a new lump appears weeks or months later, which can mean a delayed inflammatory reaction or an infection
The filler looks like it has shifted out of place
None of these are emergencies, but none of them should be left alone either.