SKformula Link
Crosslinked Sodium Hyaluronate Solution for Mesotherapy
Only to be implanted in an appropriate medical environment by appropriately trained medical doctors who are qualified or accredited in accordance with national law.
Caution: General law restricts this device to sale by or on the order of a licensed physician or properly licensed practitioner.
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
DEVICE DESCRIPTION
Composition (every 1ml)
Sodium hyaluronate 10mg
Phosphate buffer pH 7.2 q.s. 1ml
SKformula Link is a sterile, biodegradable, nonpyrogenic, viscoelastic, clear, colorless, homogenized slightly cross-linked implants. It consists of modified hyaluronic acid (HA) produced by bacteria, formulated to a concentration of 10 mg/ml in a physiologic buffer.
SKformula Link is presented in a graduated, pre-filled, disposable syringe. Each box contains one syringe, an instruction leaflet and a set of labels in order to ensure traceability. The solution in the syringe is terminally sterilized by moist heat.
INDICATIONS
SKformula Link injectable slightly cross-linked implant is indicated for injection into the dermis to improve skin appearance primarily through the moisturizing and hydrating effects of sodium hyaluronate.
MODE OF ACTION
SKformula Link is implanted to supplement the intercellular matrix and the intradermal tissue in order to restore lost anatomical structures. Its mechanism of action is based on the latest biotechnological developments in the production of injectable hyaluronic acid. The volume and the lifting capacity originate from the ability of hyaluronic acid to attract high amount of water, which is further increased by crosslinked process. Sodium Hyaluronate is degraded in the body by the same metabolic pathway as endogenous hyaluronic acid.
CONTRAINDICATIONS
SKformula Link is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
SKformula Link is contraindicated for pregnant women, breastfeeding women and minors;
SKformula Link is contraindicated in coagulation mechanism abnormalities who are using platelet agglutination inhibitors or receiving anticoagulant therapy
WARNINGS
SKformula Link is only used in medical institutions officially approved by local authority and by medical personnel who have clinical practice experience or have received relevant professional training in strict accordance with the requirements of the product instruction manual.
SKformula Link is disposable, do not sterilize again or use in batches.
Please check the product specifications and validity period before use. Do not use beyond the expiry date.
Do not use in case of damaged packages.
This product is only used for injection in the dermis and must not be injected into blood vessels. Introduction of SKformula Link into the vasculature may occlude the vessels and could cause infarction or embolization.
SKformula Link should not be used for breast injection.
PRECAUTIONS FOR USE
SKformula Link is packaged for single-patient use. Do not reuse, secondary use is possible to lead to some infectious diseases.
The maximum amount of a single dose is recommended to be no more than 6mL.
As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.
SKformula Link is to be used as supplied. Modification or use beyond the Instructions for use may adversely impact the sterility, homogeneity, and performance of the product and it can therefore no longer be assured.
After use, treatment syringes and needles may be potential biohazards. Handle and dispose of these items in accordance with accepted medical practice and applicable local, state, and federal requirements.
SKformula Link is a clear, colorless gel without particulates. In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe.
If laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after treatment with SKformula Link, there is a possible risk of eliciting an inflammatory reaction at the indications site. An inflammatory reaction is also possible if the product is administered before the skin has healed completely after such a procedure.
Failure to comply with the needle attachment instructions could result in needle disengagement and /or product leakage at the luer-lock and needle hub connection.
If the needle is blocked, do not increase the pressure on the plunger rod but stop the injection and replace the needle.
Serious incident associated with injection of SKformula Link should be reported to the manufacturer, distributor and the competent authority.
The safety of this product in combination with other products has not been proven.
Do not use quaternary ammonium salts during preoperative disinfection, because hyaluronan can precipitate in their presence.
The safety in patients under 18 years has not been established.
The used syringes or expired products should be disposed in compliance with pertinent government regulations regarding medical devices.
ADVERSE REACTIONS
The patients must be informed there they are potential side effects associated with implantation of this product, which may occur immediately or may be delayed. These include, but are not limited to:
• Inflammatory reactions(redness, oedema, erythema, etc.) which may be associated with itching or pain on pressure or both, occurring after the injection. These reactions may last for a week.
• Haematomas.
• Induration or nodules at the injection site.
• Staining or discolouration of the injection site.
• Poor effect or weak injection effect.
• Patients must report inflammatory reactions which persist for more than one week, or any other side effect which develops, to their medical practitioner as soon as possible. The medical practitioner should use an appropriate treatment.
METHOD OF USE & POSOLOGY
A. To Attach Needle to Syringe
Step 1 Remove the cap on the tip of the syringe: Hold the syringe and unscrew the cap from the syringe.
Step 2 Install the needle: Hold the syringe and insert the needle connector accurately into the Luer connector of the syringe.
Step 3 Tighten the injection needle: rotate the needle clockwise to tighten it, and there should be no skew or gap.
B. Physician Instructions
This product is designed to be injected into the dermis by an authorized medical practitioner in accordance with local applicable regulations. As precision is essential to a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for filling.
Before starting treatment, patients should be informed of the product’s indications, contra-indications, incompatibilities and potential undesirable effects.
The area to be treated should be disinfected thoroughly prior to the injection.
Follow the above attaching needle to syringe steps, depress the plunger rod until the product flows out of the needle.
The injection site can be given local anesthesia as needed.
The injection technique may vary with regard to the angle and orientation of the bevel, the depth of injection, and the quantity administered. A linear threading technique, serial puncture injections, or a combination of the 2 have been used to achieve optimal results. Injecting the product too superficially may result in visible lumps and/or discoloration.
Inject SKformula Link by applying even pressure on the plunger rod while slowly pulling the needle backward. It is important that the injection be stopped just before the needle is pulled out of the skin to prevent material from leaking out or ending up too superficially in the skin.
If the needle is blocked, do not increase the pressure on the plunger rod. Instead, stop the injection and replace the needle.
The recommended needle size is 27G-32G.
Ensure that the package of sodium hyaluronate solution for injection is complete before use.
If allergic reactions such as rash occur during the injection, the use should be stopped.
Patients may have mild to moderate injection-site responses, which typically resolve in a few days. If the treated area is swollen immediately after the injection, an ice pack can be applied to the site for a short period.
Before using this product for treatment, the physician should thoroughly understand the patient's medical history to evaluate whether this product is suitable for the patient.
The physician should instruct the patient to promptly report to her/him any evidence of problems possibly associated with the use of SKformula Link.
SPECIFICATIONS
0.5ml,1ml,1.5ml, 2ml,2.5ml, 3ml.
STORAGE AND SHELF LIFE
Store at 2℃ to 30℃
Do not freeze, Fragile.
Shelf life is 3 years.
Version number: 02
Issued date: 2026-05-08
