Active Ingredient: Cross-linked Hyaluronic Acid

Concentration: 24 mg/mL

Local Anesthetic: Lidocaine Hydrochloride (0.3% / 3 mg/mL)

Molecular Weight: High molecular weight (2.5 – 3.0 MDa)

Core Technology: PNET (Preserved Natural Entanglement Technology)

Degree of Modification (MoD): ~9% (High density)

pH Level: 6.8 – 7.5

Osmolality: 270 – 350 mOsm/kg

Rheological Data

Elastic Modulus (G’): > 400 Pa

Viscous Modulus (G”): ~ 45 Pa

Extrusion Force: 10-15 N

Hardware

Volume: 1.0 mL Pre-filled Syringe

Needle Specification: 27G ½” (Thin Wall)

Syringe Type: Ergonomic glass matrix

Clinical Application

Target Tissues: Deep dermis, subcutaneous tissue, supraperiosteal plane.

Techniques: Linear threading, serial puncture, bolus injection.

Efficacy Duration: 8-12 months.

Manufacturing & Standards

Manufacturer: Dongbang Medical Co., Ltd. (South Korea)

Facility Certification: ISO 13485:2016 (Medical Devices QMS)

Regulatory Approvals: KFDA Approved, CE Mark, GMP Compliant

Purity Metrics

Endotoxin Level: < 0.1 EU/mL (Exceeds Ph. Eur. standards)

Residual BDDE: < 2.0 ppm (Below detection limit)

Protein Load: < 0.1%

Temperature: 2°C to 25°C. Strictly prohibit freezing.

Light Exposure: Store in original packaging away from direct sunlight.

Shelf Life: 24 months from the manufacturing date.

Administration: Class III Medical Device. Restricted to licensed medical practitioners trained in advanced facial anatomy and HA injection techniques.

Absolute Contraindications: Known hypersensitivity to hyaluronic acid or lidocaine amide-type anesthetics. Patients with active cutaneous inflammation, infection at the injection site, or poorly controlled autoimmune disorders.

Adverse Events: Expected transient injection-site reactions (erythema, edema, hematoma) generally resolve within 7 days. Immediate reporting protocol required for vascular compromise symptoms.