Regional Regulation
A product is not simply “approved worldwide.” Regulatory status belongs to an exact product or variant, jurisdiction, indication, company role, and point in time. This index separates regulator-confirmed approval from conformity marking, official local product information, company-reported milestones, and evidence that was not identified.
Review date: July 31, 2026. Status can change. Verify the current local product record, IFU, approval holder, and distributor before clinical or commercial use.
How status is expressed
Section titled “How status is expressed”| Status | Meaning in this index |
|---|---|
| Regulator-confirmed | A current regulator-hosted approval, registration, labeling, or safety record was reviewed |
| Current official product information | A current local manufacturer or commercial-company page provides the market-specific intended use |
| Company-reported milestone | The manufacturer reports a certificate, license, or launch, but the controlling current regulator record was not reviewed |
| Historical conformity evidence | A dated CE or other conformity milestone is documented, but the current certificate and scope still require verification |
| Not identified in this review | No adequate product-specific primary record was found; this is not proof of absence |
Cross-region product map
Section titled “Cross-region product map”| Product | United States | European Union | South Korea |
|---|---|---|---|
| Sculptra | FDA PMA confirmed; several indication-bearing records | EU MDR certification and body expansion reported in December 2025 | Current Galderma Korea product information states a Korean intended use |
| Lanluma | Product-specific FDA approval not identified | Current Sinclair regional page displays CE 1023 and intended use | Product-specific Korean record not identified |
| AestheFill | Product-specific FDA approval not identified | REGEN reported a CE certificate in April 2021; current scope requires verification | REGEN reports a 2014 KFDA manufacturing-license milestone |
| Juvelook | Product-specific FDA approval not identified | Italian regulator safety record confirms device and manufacturer; full current certificate and indication not established here | Current official Korean page gives medical-device intended use |
| Radiesse | FDA PMA confirmed; face, hand, jawline variant, and 2026 décolleté records | Historical official CE milestones; current exact certificate and IFU still control | Current Merz Korea page gives face and hand intended use |
| Ellansé | Product-specific FDA approval not identified | Current Sinclair page states EU intended use and identifies CE 0344 and AQTIS Medical B.V. | Product-specific Korean record not identified |
“Not identified” means that this review did not locate adequate primary evidence. It must not be rewritten as “not approved,” “not sold,” or “illegal.”
Why the same word can mislead
Section titled “Why the same word can mislead”United States
Section titled “United States”FDA premarket approval (PMA) records contain an original approval and many supplements. Some supplements add indications; others concern manufacturing, sterilization, packaging, or labeling. Read the approval-order statement rather than treating every supplement as a new clinical authorization.
European Union
Section titled “European Union”CE marking indicates conformity with applicable EU requirements. For devices requiring third-party assessment, a notified body participates in conformity assessment. This differs from a single agency issuing a product-specific marketing approval. EUDAMED became mandatory for its first four modules on May 28, 2026, improving but not eliminating the need to inspect certificates, declarations, IFUs, and national records (European Commission EUDAMED overview 🔗).
South Korea
Section titled “South Korea”Product approval or certification, manufacturing license, KGMP, an advertising-review number, and a local launch describe different regulatory or commercial facts. A company page can support current local intended-use wording, but the exact MFDS product record and approved IFU remain the controlling sources.
Practitioner verification sequence
Section titled “Practitioner verification sequence”- Match the exact product, variant, concentration, and presentation.
- Identify the jurisdiction and document date.
- Confirm the legal manufacturer and local approval holder or importer.
- Read the current intended use, contraindications, warnings, preparation, and placement instructions.
- Determine whether the planned use is approved, supported only by literature, or off-label.
- Retain the governing document with the treatment record when its version matters.
Continue to United States, European Union, or South Korea for the underlying evidence and limitations.