The phrase 'it is approved'
This page is written for general readers. It does not recommend any procedure, product or clinic, and it carries no efficacy, duration or price information. Decisions about treatment belong with a qualified clinician who has examined you.
Question
What does an approval or clearance actually mean?
An approval tells you three things and withholds one. It tells you which country, which kind (cosmetic, device or medicine), and for what use. It does not tell you how well the product works. And an approval in one country has no force in another.
What an approval is a record of
An approval is a record that a product passed a defined review procedure. Nothing more and nothing less. In particular, it is not a ranking of performance. Two products holding the same classification can be entirely unlike each other.
There are three separate lanes
Even when used for the same aesthetic purpose, a product falls into one of three.
Cosmetics are reviewed on the premise of being applied to the surface. Devices are reviewed as objects placed in or acting on the body. Medicines are reviewed as drugs, and products in this lane are restricted from advertising to the general public at all.
The distinction does not stop at paperwork. It changes who may handle the product and what may be said about it. It is why this site records the classification separately for every material.
It differs by country
The same material is classified differently from market to market. That is the reason the table on this site exists.
And in some countries there is no corresponding record at all. When this site reviewed the full list of aesthetic dermal implant approvals in the United States, several materials widely used in Korea and the European Union were not on it. Absence is not a fault, but it is a different statement from “it is used abroad too”.
A classification does not tell you a mechanism
This came out of assembling the site. Two materials that do quite different things in the body hold the same classification in all three markets where it could be established, and in the United States they are even listed under the same product name.
A classification records the route by which a product entered the market, not what happens in tissue. “Same grade” does not mean “same principle”.
What could not be established is left empty
The regulatory table on this site has many empty cells. Filling them would look better, but filling a cell that cannot be sourced makes the whole table unreliable. So established cells link to the source document, and cells that could not be established say so.
What to check first
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Which country's approval is it?
A United States approval has no force in Korea and the reverse is equally true. When this site checked, some materials treated as devices in Korea and the European Union had no corresponding approval record in the United States at all.
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Is it a cosmetic, a device or a medicine?
The three are reviewed differently, and the range of what may be said in advertising differs too. In particular, injecting something approved for topical use falls outside the terms of that approval.
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What is the approval for — this product, or this material?
Each product is approved separately even when the material is the same. That a record exists for the material does not mean one exists for the product in front of you.
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Does approved mean it works well?
No. An approval records that a defined standard was met; it is not a ranking of performance. Two products in the same classification can be made entirely differently.
What this page does not say
This page does not confirm the approval status of any individual product. It covers only what the word carries and what it does not. The regulatory classifications organised on this site are limited to what public sources established and are not legal advice; where nothing could be established, nothing is assumed and the cell is marked as such. An approval also does not mean a product is safe or effective.