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# Warning on Needle-free Devices for Dermal Fillers
- URL: https://www.fdaweb.com/warning-on-needle-free-devices-for-dermal-fillers/
- Published: 2021-10-08T12:00:00.000Z
- Updated: 2026-09-14T17:18:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150331

FDA has issued a [warning](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZH-2F-2BdT2Hfvce-2B9YoPQjyr3PmmdMTbAYohayJ7Xodgn-2BhbHHpHrQFEH1skvjiyHulU7wBL3FcbdXx0F3PhCjbS1AszjuElwQFsnIGNyJfve6rZK9vKeuf7n5F7wI2mBZtTFCRfNW-2FlHl3rcGYcEWwUBNSODP8Y3mThXpLDLKVYNCLVBszyJit5&ref=fdaweb.com) to health care professionals to not use needle-free devices such as hyaluron pens for injecting hyaluronic acid or other lip and facial fillers (dermal fillers or fillers). The agency says serious adverse events have been reported in connection with their use, such as permanent damage to the skin, lips and eyes. 

“Patients and healthcare providers should know that FDA has not approved any dermal fillers for over-the-counter sale for at-home use or for use with needle-free injection devices,” FDA says. “These unapproved needle-free devices and fillers are often sold directly to customers online, bypassing consultation with a licensed health care provider, a critical safety measure for patients to make informed decisions about their personal health.”