South Korea Regulation
In South Korea, product approval, a manufacturing license, KGMP certification, advertising review, and commercial availability are separate facts. The exact MFDS product record and approved Korean IFU should control clinical claims; current official local product pages can support intended-use wording when clearly identified as company-hosted information.
Review date: July 31, 2026.
Evidence map
Section titled “Evidence map”| Product | Korean evidence reviewed | Supported statement | Boundary |
|---|---|---|---|
| Sculptra | Current Galderma Korea brand page | Korean intended use, placement level, and 1-vial presentation | Confirm exact current approval number and IFU locally |
| AestheFill | REGEN official history | Company reports an April 2014 KFDA manufacturing license | Does not by itself establish the complete current product approval |
| Juvelook | Current official Korean product page | Medical-device category and Korean intended-use wording | Exact family presentation and current approval record still matter |
| Radiesse | Current Merz Aesthetics Korea page | Korean face-wrinkle and dorsal-hand intended use | Does not import the 2026 US décolleté indication |
| Lanluma | No adequate Korean primary product record identified | Status not established in this review | Do not infer from EU or overseas use |
| Ellansé | No adequate Korean primary product record identified | Status not established in this review | Do not infer from EU CE information |
Sculptra
Section titled “Sculptra”Galderma Korea’s current brand page describes Sculptra’s purpose as injection of PLLA for temporary improvement of adult facial wrinkles through physical restoration. It states injection into the deep dermis or subcutaneous layer and a one-vial box presentation (Galderma Korea 🔗).
This Korean wording is distinct from:
- the US HIV-lipoatrophy and indication-bearing PMA history
- the US 2023 cheek-wrinkle supplement
- the EU 2025 body-indication certification
- Galderma’s broader global IFU
Juvelook
Section titled “Juvelook”VAIM’s current Korean site identifies Juvelook as a medical device in the tissue-repair-material category and states use of polylactide and HA by subcutaneous injection for temporary improvement of adult facial wrinkles through physical restoration (Juvelook Korea 🔗).
The current Korean family contains several presentations. Do not cite one family-wide sentence without confirming which exact named product, content, approval record, and IFU apply.
Radiesse
Section titled “Radiesse”Merz Aesthetics Korea describes Radiesse Injectable Implant as a tissue-repair material used by subcutaneous injection of synthetic CaHA for temporary improvement of adult facial wrinkles and temporary restoration of volume loss in the dorsum of the hands (Merz Aesthetics Korea 🔗).
The page also displays a medical-device advertising-review number. That number supports review of the advertisement; it is not a substitute for the product approval certificate.
The US March 31, 2026 diluted décolleté indication does not alter the Korean intended use.
AestheFill
Section titled “AestheFill”REGEN’s official history reports that AestheFill and PowerFill obtained a KFDA manufacturing license in April 2014 (REGEN history 🔗). This establishes a company-reported manufacturing milestone.
It does not independently establish:
- the complete current Korean intended use
- current approval or renewal status
- every formulation or presentation
- an approval-holder role beyond what the product record states
Use the exact current MFDS record and Korean IFU before making a clinical approval claim.
Lanluma and Ellansé
Section titled “Lanluma and Ellansé”No adequate product-specific Korean regulator or current official Korean product record was identified for Lanluma or Ellansé in this review. This is an evidence gap, not a declaration that either product is unavailable, unapproved, or prohibited.
Korean record check
Section titled “Korean record check”For current use, verify:
- exact Korean product name and model or presentation
- MFDS approval, certification, or notification number and validity
- approved intended use and placement language
- manufacturer, importer, and approval-holder roles
- current Korean IFU, warnings, and preparation
- KGMP and manufacturing-site information where relevant
- whether an advertising statement is narrower or broader than the approval record
Return to the regional overview before comparing Korean wording with US PMA indications or EU conformity scope.