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Medical Device

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Medical Device

[Tissue Restoration Biomaterial]
REGENESS ULTRA FILLER
리겐에스 울트라 필러 / Medical Device Class III
Classification
Biomaterial graft and prosthesis
Appearance
Transparent gel type
How Supplied
3 mL × 3 syringes per box.
Active Ingredients
Cross-linked hyaluronic acid (24 mg/mL), Lidocaine hydrochloride (3 mg/mL), Phosphate-buffered saline
Indications and Usage
Restoration of volume and contouring of the face and body. Indicated for the temporary improvement of facial wrinkles in adults through physical restoration by subcutaneous injection of cross-linked hyaluronic acid containing lidocaine.
Dosage and Administration
To ensure safe use of the product, it is essential to correctly attach the needle to the syringe. 1) Firmly hold the white ribbed section of the syringe's Luer lock adapter between your thumb and index finger. With the other hand, twist the protective cap at a 90-degree angle to remove it. 2) While holding the Luer lock adapter, push and twist the needle clockwise until resistance is felt. Failure to do so may result in needle detachment or product leakage from the Luer lock connection. 3) Finally, hold the Luer lock with one hand and the protective cap with the other. Pull both hands in opposite directions to remove the cap from the needle. The injection depth may vary from subcutaneous to supraperiosteal, depending on the treatment area. After use, the syringe, any remaining product, and the needle should be treated as potentially biohazardous waste and disposed of in compliance with applicable regulations.
Shelf Life
24 months from the date of manufacture.
Storage
Store between 2°C and 25°C. Avoid direct sunlight and freezing.

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