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Product identity
What was that, exactly?
Type the name as it was said to you or printed on the box — or a number from it: an NDC, a device identifier or full UDI, a 510(k), PMA or application number. A name is matched against this site’s registry; a number can be looked up in FDA’s own records, with any recall filed under it. A match says a record exists. It never says the vial or device in front of you is that product.
Try:
A PMA number. Press the lookup button to search FDA records.
Registry match
Belotero Balance
Merz North America, Inc. · Hyaluronic acid fillers
Injection into the mid-to-deep skin layer to correct moderate to severe facial wrinkles and folds, such as nasolabial folds
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 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.
Injection into the mid-to-deep skin layer to correct moderate to severe facial wrinkles and folds, such as nasolabial folds
Volume augmentation to improve hollow areas under the eyes (infraorbital hollow), in adults over 21 (approved 2023, P090016/S050)
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 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.
Look it up in FDA and National Library of Medicine databases: the record it belongs to, who holds it, and any recall or enforcement report filed under it.
Sends only “P090016” to this site, which asks FDA and the National Library of Medicine. Nothing else on this page or in your Booking File is sent, and nothing is stored.
Your booking file
Record what you found
Did you see Belotero Balance itself — the box, vial or device panel?
Your file lives in this browser. Recording waits until it has been read.