United States Regulation

The core products with confirmed FDA PMA records in this index are Sculptra and Radiesse. Their US indications come from specific original PMAs and indication-bearing supplements—not from material identity, international labels, or general clinical use.

Review date: July 31, 2026.

Confirmed FDA product records

Product	FDA record and applicant	Indication-bearing milestones	Current reading boundary
Sculptra	PMA P030050; Q-Med AB	2004 HIV facial lipoatrophy; 2009 nasolabial folds and other qualifying facial wrinkles; 2023 cheek fine lines and wrinkles in immune-competent subjects	Later process supplements do not automatically add indications
Radiesse	PMA P050052; Merz North America, Inc.	2006 moderate-to-severe facial wrinkles and folds; 2015 dorsal-hand volume loss; 2021 Radiesse (+) jawline contour loss; 2026 1:2 diluted décolleté wrinkles	Product variant, age, preparation, depth, and indication remain linked

The FDA explains that approved fillers and their indications should be verified through the PMA database using product codes LMH for face and PKY for hand products (FDA approved-filler guidance 🔗).

Sculptra

The original August 3, 2004 approval concerned restoration or correction of facial fat loss in people with HIV (FDA P030050 🔗).

The July 28, 2009 S002 supplement added Sculptra Aesthetic for shallow-to-deep nasolabial-fold contour deficiencies and other facial wrinkles in immune-competent people where the labeled technique was appropriate (FDA P030050/S002 🔗).

The April 25, 2023 S039 supplement added correction of fine lines and wrinkles in the cheek region for immune-competent subjects (FDA P030050/S039 🔗; current indication summary and labeling 🔗).

The June 22, 2026 S055 supplement concerns an additional manufacturing autoclave. It is a current PMA record, but it is not an indication expansion (FDA P030050/S055 🔗).

Radiesse

The December 22, 2006 original P050052 approval covered subdermal correction of moderate-to-severe facial wrinkles and folds such as nasolabial folds (FDA P050052 🔗).

Later indication-bearing supplements include:

• June 4, 2015: hand augmentation for volume loss in the dorsum of the hands (FDA P050052/S049 🔗)
• September 1, 2021: Radiesse (+) for deep augmentation of moderate-to-severe jawline contour loss in adults over 21 (FDA P050052/S129 🔗)
• March 31, 2026: Radiesse diluted 1:2 with 0.9% sterile saline for subdermal correction of décolleté wrinkles in patients 22 years and older (FDA P050052/S162 🔗)

The 2026 décolleté approval is an indication-specific preparation. It does not convert every diluted or hyperdiluted CaHA use into an approved US use.

Other core products

This review did not identify product-specific FDA approval records for Lanluma, AestheFill, Juvelook, or Ellansé in the FDA approved-filler and PMA sources reviewed.

That statement means only:

• do not cite an international CE mark, Korean product page, patent, study, or US distributor as FDA approval
• verify the FDA database again before making a current claim
• do not treat absence from this review as proof of market status or legality in an individual situation

The FDA advises clinicians to use FDA-approved fillers and notes that approved indications vary by exact product (FDA dermal-filler information 🔗).

Approval is narrower than the brand name

An FDA-approved brand may have multiple variants and indication-bearing supplements. Confirm the exact product, indication, anatomical area, patient population, preparation, and current labeling.

US record check

For a clinic record or publication, retain:

1. PMA and supplement number
2. decision date
3. applicant
4. approval-order statement
5. current clinician and patient labeling
6. whether the supplement changes indication or only manufacturing, packaging, or labeling

Return to the regional overview before comparing US wording with the EU or Korea.