Do Not Use Needle-Free Devices for Injection of Dermal Fillers – FDA

The U.S. Food and Drug Administration (FDA) is warning the public and health care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid (HA) or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers.
The FDA is aware of serious injuries and in some cases, permanent harm to the skin, lips, or eyes with the use of needle-free devices for injection of lip and facial fillers.

The FDA has not evaluated the safety or effectiveness of needle-free devices for injection of fillers. The FDA also has not approved the marketing of needle-free devices for injection of these products.  FDA-approved dermal fillers are intended for prescription use only and for use with a syringe with a needle or cannula (a small flexible tubing with a blunt tip that is inserted under the skin).

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FDAFDA 08.10.2021
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