Sardenya Shape

Sardenya Shape

Sardenya Shape is a high-density cross-linked hyaluronic acid (HA) dermal filler from RFBio Co., Ltd., South Korea, designed for volumising and facial contouring. It contains 24 mg/ml HA and 0.3% lidocaine, and is intended for areas such as the cheeks, chin, jawline and nasolabial folds, as specified in the official Instructions for Use (IFU). It is supplied in a 1.1 ml pre-filled syringe. For use by licensed physicians only.

Key Features

• Volumising Gel: Positioned between Sardenya Deep and Sardenya Implant, for volume restoration and contouring.
• HoPE Technology: The manufacturer’s Homogeneous Process and Equilibration method, designed for uniform cross-linking and consistent viscoelasticity.
• High Storage Modulus: According to the manufacturer, the gel resists deformation, which supports lifting and shaping.
• HA 24 mg/ml: Cross-linked hyaluronic acid gel.
• With 0.3% Lidocaine: Included to help reduce discomfort during injection.
• Reversible: Hyaluronic acid can be dissolved with hyaluronidase by a qualified practitioner.

The Sardenya Range

The Sardenya range includes four gels of increasing density. The physician selects the product according to the treatment area, tissue depth and desired result.

• Sardenya Fine: The lightest gel, for fine lines and the lip contour.
• Sardenya Deep: Medium density, for moderate to deep wrinkles, nasolabial folds and lip contouring.
• Sardenya Shape: Volumising gel for contouring the cheeks, chin and jawline.
• Sardenya Implant: The densest gel, for structural augmentation in deeper layers.

Intended Use

• Cheek volume and contouring
• Chin augmentation
• Jawline definition
• Nasolabial folds

Treatment area, injection depth, technique and volume must follow the official Instructions for Use and the treating physician’s assessment. Results and duration vary between individuals.

Product Specifications

• Brand: Sardenya™
• Product: Sardenya Shape
• Manufacturer: RFBio Co., Ltd.
• Origin: South Korea
• Composition: Cross-linked hyaluronic acid 24 mg/ml, lidocaine 0.3%
• Gel Density: High (volumising)
• Technology: HoPE (Homogeneous Process and Equilibration), manufacturer’s description
• Injection Depth: Deep dermis to subcutaneous, as specified in the IFU
• Contents: 1 × 1.1 ml pre-filled syringe
• Product Type: Hyaluronic acid dermal filler (medical device)

Administration

• For use only by licensed physicians trained in facial anatomy, dermal filler injection techniques and the management of filler complications.
• Inject under aseptic conditions.
• Injection depth, technique (needle or cannula), volume and treatment interval must follow the IFU and the treating physician’s judgment.
• Do not self-administer.

Precautions

• Common reactions include redness, swelling, pain, tenderness, itching and bruising at the injection site.
• Lumps, nodules, asymmetry, product migration, infection and delayed inflammatory reactions may occur.
• Accidental injection into a blood vessel can cause vascular occlusion, skin necrosis and, rarely, visual impairment or blindness. The nasolabial folds, cheeks and chin contain major blood vessels and require particular care.
• Contains lidocaine. Not suitable for people with known allergy to lidocaine or other amide-type local anaesthetics.
• Hyaluronic acid can be dissolved with hyaluronidase. Practitioners should keep hyaluronidase and an emergency protocol available.
• Seek medical attention immediately for severe or increasing pain, skin blanching or colour change, or any change in vision after treatment.
• Do not use if the packaging is damaged, the syringe is cracked or the product is past its expiry date.
• Single use only. One syringe, one patient. Keep out of reach of children.

Who Should Consult a Physician First

• People with known allergy to hyaluronic acid, lidocaine or amide-type local anaesthetics
• Pregnant or breastfeeding women
• People with infection, inflammation, cold sores or skin disease at the treatment area
• People with bleeding disorders or taking medicines that affect blood clotting
• People with autoimmune disease, a history of keloids or severe allergies
• People with permanent fillers or implants in the treatment area
• People under 18 years of age

Storage

Store according to the instructions on the carton and in the IFU, in a dry place away from direct sunlight. Do not freeze. Refer to the carton for the expiry date.

Package Contents

• 1 × 1.1 ml pre-filled syringe of Sardenya Shape
• Instructions for Use

Important Notice

For professional healthcare use only. This information is for general product reference. It does not replace medical advice, the official Instructions for Use or local regulations. This product is not intended to diagnose, treat, cure or prevent any disease. Results vary between individuals.