Filler

gisell_vis

Product Information

Product
Product Name GISELLELIGNE
Model Name CGGL Universal – 1 CGGL Signature 1-1 CGGL Signature – 2-1
Volume 2 X 1ml 2 X 1ml 2 X 1ml
How to keep or store 2℃ ~ 30℃, avoid sunlight and freezing
Purpose of Use As biomaterials for tissue repair, cross-linked hyaluronic acid is injected hypodermically and used to temporarily improve an adult’s facial wrinkles through physical restoration
Precautions

Before the first operation, the physician should be fully trained by the manufacturer or seller on the procedure methods to perform the procedure.

Check the expiration date on the product label.

Ensure that sterilization has not been impaired before use.

Before the procedure, the physician should explain to the patient the indications, contraindications, tabulations and possible side effects of the product.

The physician should read and comprehend the instruction manual of the product.

How to Use

Disinfect the treatment area sufficiently before the procedure.

After removing the syringe cap, rotate the needle in a clockwise direction to fully engage.

Remove the protective cap of the needle by pulling it straight in line with the syringe.

Push the piston until the drop of filler drops to the tip of the needle tip before injection.

Fillings are injected into the skin. After inserting the needle sufficiently, slowly back out and inject with constant force or Insert the needle into the target depth, inject a small amount, remove it, and inject it in the near site in the same way (continuous puncture) or do both.

Cease the injection just before removing the filler so that the filling does not overflow.

Gently massage the injected area so that the filler is correctly positioned.

Compress the treatment area with a wet pad for a few minutes to avoid swelling.

How to Keep and Manage after Use

This product is disposable, so dispose of it after use and do not reuse.

Prohibited Contents

Do not inject into the blood vessels.

Do not apply around eyes such the middle of the forehead.

Do not operate in excessive amounts.

The following patients are not treated.

  • Patients who tend to have keloids or hypertrophic scars
  • If the skin is inflamed or infected (patients who are sensitive to inflammation or infection should not be treated until this condition has healed).
  • Patients with hemorrhage-related disorders and pathologies
  • Patients with allergies to bacteria
  • Patients with hypersensitivity to lidocaine or sodium hyaluronate
  • Patients with a history of autoimmune disease
  • Patients with acute rheumatic fever due to cardiac complications
  • Patients with severe allergy and hypersensitivity
  • Patients already with permanent implants
  • Women who are pregnant or lactating
  • Minors are prohibited from use

Do not apply to areas with skin disease or inflammation.

Do not use in conjunction with other skin treatments such as laser treatment, chemical peeling, or dermabrasion.

Precautions

Doctors who have been trained in the operation of this product should conduct the treatment.

Before the procedure, the doctor should explain to the patient the indications, contraindications, and potential side effects of the product.

The area of treatment should be cleaned in advance with proper disinfectant and the patient should be examined for the necessity of anesthesia before starting treatment.

Injection of a patient with herpetic eruption may cause herpetic relapse.

Safety is not established for patients susceptible to hyperpigmentation.

Safety and efficacy for long-term use other than the period revealed through clinical studies were not confirmed.

The safety and efficacy of lip augmentation was not established.

There is no clinical data on the efficacy and tolerability of this product when injected into a site already treated with other fillers.

Patients undergoing anticoagulant treatment should be informed of the increased risk of hematoma and bleeding during infusion.

Patients should avoid aspirin and excessive vitamin intake before the procedure.

Patients should not put make up for 24 hours after the procedure, avoid exposure to sunlight, ultraviolet rays, extreme coldness for extended periods of 2 weeks and avoid the use of sauna.

If the needle is clogged, do not insert excessive pressure and replace the needle.

Incompatibility

Hyaluronic acid can cause precipitation by quaternary ammonium and chlorohexidine, such as benzalkonium chloride, a disinfectant, so do not store this product with the product or contact surgical instruments that use the material.

Adverse Reactions

The practitioner should explain to the patient the following potential side effects after the procedure.

  • Inflammatory reactions with pain due to itching and pressure after injection (Redness, oedema, erythema, etc.), and these reactions last for hours to weeks
  • Bleeding or hematoma at the injection site
  • Injection site hardening, discoloration, insufficient effect
  • Cases of necroses in the glabellar region, granulomas, hypersensitivity, and abscess have been reported in the use of other hyaluronic acid products
  • Patients should inform the inflammation reaction or other secondary side effects lasting more than one week to the practitioner, and the practitioner should treat them appropriately.
Warning

Ensure that sterilization has not been impaired before use.

Do not use when damaged.

Check the expiration date on the product label.

Do not mix and use with other products.

Discard the syringe and any remaining product after use.

Do not re-sterilize.

Do not reuse.

※ This product is a ‘medical device’, please read the ‘Usage Precautions’ and ‘How to Use’ carefully before using.

Advertisement Review Completed : Review No. 2019-I10-03-0183