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Yes. FDA approved Skinvive by Juvéderm on May 11, 2023 (PMA P110033, supplement S059) for cheek skin smoothness, and added a neck-lines indication on June 11, 2026.
| Ticker | Company | 1-year change |
|---|---|---|
| ABBV | AbbVie (Allergan Aesthetics) | +11.6% |
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Corrected September 25, 2026: An earlier version of this page said Skinvive received 510(k) clearance in September 2023 and was cleared for the cheeks and neck. That was wrong. Skinvive was approved through the premarket approval (PMA) pathway in May 2023 for cheek skin smoothness; the neck-lines indication was added in June 2026.
Yes. The U.S. Food and Drug Administration approved Skinvive by Juvéderm on May 11, 2023, as supplement S059 to Allergan's premarket approval application P110033.
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Skinvive's neck-lines indication dates from June 2026; its original 2023 approval covered cheek skin smoothness only.
The record. The May 11, 2023 approval covers intradermal injection to improve facial skin smoothness of the cheeks in adults over the age of 21. On June 11, 2026, FDA approved an expanded indication (supplement S099): intradermal injection to improve skin smoothness of the cheeks, and intradermal and/or subdermal injection to reduce neck lines for improvement of neck appearance, in adults over the age of 21.
Why the pathway matters. Dermal fillers go through premarket approval (PMA), the FDA route for Class III devices, so the correct term is "approved," not "cleared." 510(k) clearance applies to lower-risk devices.
The parent application. P110033 is the premarket approval FDA granted on October 22, 2013 for Juvéderm Voluma XC, for cheek augmentation to correct age-related volume deficit in the midface. Skinvive was approved as a supplement to it rather than under a new application.
What this means in the treatment room. Skinvive's approved uses are cheek skin smoothness and, since June 2026, neck lines, both in adults over 21. Other areas are off-label.
Related approvals. Other injectables in FDA's PMA database include the RHA line (P170002, first approved October 19, 2017), Sculptra (P030050, first approved August 3, 2004) and Evolysse Smooth and Evolysse Form (P240022, February 13, 2025). Each has its own approved indications, so check the specific product and area before you treat.
How to verify. Search the PMA number in FDA's PMA database. The original approval and each supplement are listed with dates and approval statements.
Business information, not medical or legal advice. Verify current status and labeling at FDA.gov before purchasing or treating.
Source: original report ↗
Yes. FDA approved Skinvive by Juvéderm on May 11, 2023, as supplement S059 to Allergan's PMA P110033, to improve facial skin smoothness of the cheeks in adults over 21.
Yes, since June 11, 2026, when FDA approved an expanded indication to reduce neck lines in adults over 21.
No. It was approved through premarket approval (PMA), the pathway for Class III devices.
Business information, not medical or legal advice. Verify product status at FDA.gov.
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