Elasty Plus 1CC: Navigating Regulatory Status and Market Access

Elasty Plus 1CC is a hyaluronic acid dermal filler manufactured by Dongbang Medical, a South Korean company. This product is part of a broader range of aesthetic solutions developed by the brand. For professionals, understanding the product's origin and manufacturer is the first step in verifying its authenticity and regulatory standing.

Dongbang Medical's commitment to manufacturing standards often underpins the certifications sought for their products. Professionals interested in the full range of HA fillers can explore our Hyaluronic acid dermal filler catalog.

Regulatory approvals are critical indicators of a product's manufacturing quality and safety profile. For Elasty Plus 1CC, the following certifications are typically relevant:

• KFDA (Korean Ministry of Food and Drug Safety): As a South Korean-manufactured product, Elasty Plus 1CC is expected to hold KFDA approval for its domestic market. This signifies adherence to South Korean medical device regulations.
• CE Mark: [VERIFY: CE Mark status for Elasty Plus 1CC (as Class III Medical Device)] The CE Mark is crucial for market access within the European Economic Area (EEA). It indicates conformity with EU health, safety, and environmental protection standards.
• FDA (U.S. Food and Drug Administration): [VERIFY: FDA approval status for Elasty Plus 1CC] Gaining FDA approval is a rigorous process, primarily for the U.S. market, and signifies specific clearances for use.
• GMP (Good Manufacturing Practice): Manufacturers like Dongbang Medical typically operate under GMP guidelines, ensuring consistent quality control in production. [VERIFY: GMP certification for Dongbang Medical's facilities producing Elasty Plus 1CC]
• ISO (International Organization for Standardization): ISO certifications, such as ISO 13485 for medical devices, confirm a quality management system. [VERIFY: ISO 13485 certification for Dongbang Medical's manufacturing processes relevant to Elasty Plus 1CC]

The legal status of Elasty Plus 1CC varies significantly across different international markets, depending on local regulatory frameworks and specific product registrations.

Professionals must verify the specific import and use regulations for their operational jurisdiction. Other products in the HA filler category, such as Elasty Plus Non-Lido 2CC, will follow similar regulatory pathways.

Parallel imports involve sourcing authentic products from one market and introducing them into another where they are already approved and marketed. While legal in many jurisdictions under specific conditions, professionals must exercise extreme caution.

The risks include variations in packaging, labeling, instructions for use (IFU), and sometimes formulation intended for different climates or regulatory bodies. Suppliers of parallel imported Elasty Plus 1CC must provide comprehensive documentation proving authenticity and adherence to cold chain protocols. Any discrepancies can lead to compliance issues for the clinic. For guidance on other product regulations, refer to resources like the Gouri Standard Regulatory Status.

When sourcing Elasty Plus 1CC, professionals should demand specific documentation from their suppliers. This protects both the clinic and its patients by ensuring product integrity and regulatory compliance. Key documents include:

• Certificate of Authenticity (COA) / Certificate of Analysis (COA): Verifies the product's origin and quality. A COA from the manufacturer, or a supplier-issued COA tracing back to the manufacturer, is essential.
• Lot Numbers and Expiry Dates: Must be clearly visible and match accompanying documentation. Traceability is paramount.
• Cold Chain Documentation: Proof that the product has been maintained within its specified temperature range during transit and storage, crucial for HA fillers.
• Regulatory Certificates: Copies of KFDA, CE Mark, or other relevant market-specific approvals should be available upon request. These demonstrate the product's official clearance for sale and use in specific regions.

Wholesale pricing for Elasty Plus 1CC reflects its market position and the supply chain. For illustrative purposes, a unit price might be around $64.6, with tiered discounts offered for larger volumes. This structure incentivizes bulk purchases for clinics and resellers, optimizing procurement costs.

Volume tiers often include incremental discounts: for example, 11 units might receive a 4% discount, 21 units 5%, 31 units 6%, and 51+ units 8%. Such pricing models are standard for distributors providing products like Elasty Plus 1CC, and similar structures apply to other popular fillers such as D.Fill Soft and Hyaldew.