Inside MedSpa
Yes. FDA approved Evolysse Smooth and Evolysse Form on February 13, 2025 (PMA P240022) for moderate to severe dynamic facial wrinkles and folds in adults 22 or older.
Get the free Inside MedSpa brief by email
The free Inside MedSpa brief · no card · unsubscribe anytime. Privacy.
Corrected September 25, 2026: An earlier version of this page said the Evolysse filler line launched in 2023. That was wrong. FDA approved Evolysse Smooth and Evolysse Form on February 13, 2025.
Yes. The U.S. Food and Drug Administration approved Evolysse Smooth and Evolysse Form on February 13, 2025 under premarket approval application P240022. The applicant is Symatese.
Get the recalls and state-law changes that hit your treatment room, in your inbox — free. Unsubscribe in one click.
The free Inside MedSpa brief · no card · unsubscribe anytime. Privacy.
Evolysse was approved in February 2025, not 2023.
The record. The approval covers dermal and subdermal injection to correct moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds, in adults 22 years or older. Later supplements to P240022 add no new indications: FDA approved the protocol for a post-approval study on September 3, 2025 (supplement S001), a change to that study's informed consent form on December 18, 2025, a syringe plunger-rod design change on December 19, 2025, and a manufacturing-process change on February 27, 2026. A post-approval study means the applicant keeps collecting safety and effectiveness data after approval.
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.
What this means in the treatment room. Evolysse Smooth and Evolysse Form are approved for moderate to severe dynamic facial wrinkles and folds in adults 22 or older. Lips, cheeks and other areas are off-label unless FDA approves them later.
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 Skinvive by Juvéderm (P110033/S059, May 11, 2023). 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 Evolysse Smooth and Evolysse Form on February 13, 2025 under PMA P240022. The applicant is Symatese.
Dermal and subdermal injection to correct moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds, in adults 22 years or older.
February 13, 2025. It was not on the U.S. market in 2023.
Business information, not medical or legal advice. Verify product status at FDA.gov.
Get the recalls and state-law changes that hit your treatment room, in your inbox — free. Unsubscribe in one click.
The free Inside MedSpa brief · no card · unsubscribe anytime. Privacy.
https://insidemedspa.com/article/is-evolysse-fda-approved/
No comments yet — start the conversation.
FDA decisions, recalls and the rules you operate under, drafted from the source documents and sent free by email.
Get the free brief The free Inside MedSpa brief · no card · unsubscribe anytime.