The record. The original 2004 approval was for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. On July 28, 2009, FDA approved Sculptra Aesthetic (supplement S002) for use in immune-competent people as a single regimen to correct shallow to deep nasolabial fold contour deficiencies and other facial wrinkles for which a deep dermal grid-pattern (cross-hatch) injection technique is appropriate. On April 25, 2023, FDA approved an indication (supplement S039) for correction of fine lines and wrinkles in the cheek region in immune-competent subjects.
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. Sculptra's aesthetic indications are specific: nasolabial fold contour deficiencies and other facial wrinkles suited to the cross-hatch technique, and fine lines and wrinkles in the cheek region, in immune-competent patients. Other areas are off-label.
Related approvals. Other injectables in FDA's PMA database include the RHA line (P170002, first approved October 19, 2017), Skinvive by Juvéderm (P110033/S059, May 11, 2023) 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.
