SoftFil Precision Micro Cannulas (Box of 20)

SoftFil

Medical device – needles & cannulas

Blunt tip dermal filler microcannulas with pre-hole needles

CE Marked medical device (typically Class IIa) for use in the European Economic Area for hypodermal injection procedures.
Manufactured under an ISO 13485 Compliant quality management system for medical devices (manufacturer level).
Sterile, single Use device in accordance with applicable EU / UK medical device and sterilisation standards.
Intended for use only by certified medical practitioners, following SoftFil’s Instructions for Use and local regulatory requirements.

CE Marked medical device (typically Class IIa) for use in the European Economic Area for hypodermal injection procedures.
Manufactured under an ISO 13485 Compliant quality management system for medical devices (manufacturer level).
Sterile, single Use device in accordance with applicable EU / UK medical device and sterilisation standards.
Intended for use only by certified medical practitioners, following SoftFil’s Instructions for Use and local regulatory requirements.

Blunt tip dermal filler microcannulas with pre-hole needles

Description

SoftFil Precision micro-cannulas are sterile, single-use, blunt tip cannulas specifically designed for the injection of dermal fillers and other aesthetic injectable products. They are available in a wide range of gauges from 14G to 30G and lengths from 25 mm to 90 mm, allowing tailored treatment of facial and body areas. Each kit contains one siliconized stainless-steel microcannula with centimetric graduations and a matching sharp pre-hole (stylet) needle, enabling controlled entry-point creation and atraumatic subcutaneous tunnelling. The design incorporates an extra-large internal calibre for smoother product flow, a round atraumatic tip, a red dot on the hub to indicate the side-port orientation and a special surface treatment to optimise gliding and patient comfort.

Bnefits

Blunt, round tip microcannula slides through tissue planes rather than cutting, helping to reduce the risk of vascular injury and bruising compared with sharp needles.
Extra-large internal calibre in relation to gauge facilitates smooth injection of fillers, including higher-viscosity products.
Centimetric graduations along the cannula shaft assist with consistent injection depth and symmetrical product placement.
Proprietary surface treatment and siliconized stainless steel provide excellent gliding and low friction for improved handling and patient comfort.
Red dot on the hub clearly indicates the orientation of the side port, supporting precise directional filler placement.
Wide size range (multiple gauges and lengths) allows selection adapted to each indication, anatomical area and injection technique (nappage, volumising, contouring, etc.).
Each cannula is supplied with a matching sharp pre-hole needle (stylet), enabling easy creation of an entry point with minimal trauma.
CE-marked, sterile, single-use medical device manufactured under medical-grade quality standards for use by trained healthcare professionals.

Indications

Hypodermal and subcutaneous injection of approved dermal fillers (hyaluronic-acid and non-HA fillers) in the face and body.
Aesthetic injection procedures such as volumising, contouring and correction of wrinkles, folds and depressions (e.g., cheeks, temples, nasolabial folds, marionette lines, lips, perioral area, jawline).
Nappage and biorevitalisation techniques in areas such as the face, arms and breast, in accordance with local clinical protocols.
Injection of other medical devices or drugs approved for hypodermal administration where a blunt microcannula is appropriate, as per the product’s instructions for use.

Composition

Cannula shaft: siliconized medical-grade stainless steel with proprietary low-friction surface treatment.
Tip: round, blunt atraumatic tip with lateral side port near the cannula end for nearest-to-tip filler delivery.
Markings: centimetric graduations along the shaft to aid in controlling injection depth.
Hub: rigid polymer Luer Lock hub with a coloured red dot indicating the position of the side port for orientation.
Pre-hole needle: matching sharp stainless-steel stylet (pre-hole needle) supplied in each kit for creating the entry point.
Sterilisation: sterile, single-use devices typically sterilised with ethylene oxide (EO) gas.

Formulation

Sterile, single-use blunt tip microcannula kits, each containing one microcannula and one sharp pre-hole needle.
Available gauges typically range from 14G to 30G with lengths from approximately 25 mm to 90 mm, in both standard and XL variants depending on size.
Class IIa medical device intended for use only by certified medical practitioners trained in aesthetic injection techniques.

Packaging

Box of 20 kits: 20 sterile SoftFil Precision microcannulas and 20 corresponding sharp pre-hole needles.
Each kit is individually packaged in a sterile blister or pouch with clear labelling (gauge, length, lot number and expiry date).
Outer carton typically includes device description, quantity, reference codes, manufacturer and distributor information and regulatory symbols.

Usage

Check the expiry date and integrity of the sterile blister or pouch before use; do not use if packaging is damaged or opened.
Prepare the patient and treatment area using appropriate aseptic technique, including skin disinfection and mapping of anatomical landmarks and injection plan.
Use the supplied sharp pre-hole (stylet) needle to create a small entry point through the skin at the chosen site and depth.
Attach the SoftFil microcannula securely to a Luer Lock syringe prefilled with the selected dermal filler or injectable product, ensuring a firm connection.
Insert the blunt cannula through the pre-made entry point and advance gently along the desired subdermal or hypodermal plane, following natural tissue paths with minimal force.
Use the red dot on the hub to orient the side port and deliver small, controlled aliquots of product as you withdraw or fan the cannula, according to the chosen technique (e.g., linear threading, fanning, nappage).
Continuously monitor patient comfort and tissue response; if unusual pain, blanching or strong resistance occurs, stop immediately and evaluate for possible intravascular placement following local safety protocols.
After completing injections, carefully withdraw the cannula, apply gentle pressure and/or cooling to reduce swelling or bruising as required and massage the area according to the filler manufacturer’s recommendations.
Dispose of both the used cannula and pre-hole needle immediately in an approved sharps container; never reuse or re-sterilise SoftFil microcannulas.
Only trained healthcare professionals familiar with facial and body anatomy and cannula-based injection techniques should use this device, in accordance with the SoftFil Instructions for Use and local regulations.

Contraindications

Do not use for intravascular injection; SoftFil microcannulas are intended for hypodermal / subcutaneous injections only.
Do not use in areas with active skin infection, inflammation, open wounds or compromised skin integrity at the intended injection site.
Use caution or avoid in patients with known hypersensitivity to stainless steel or other component materials, or to the injectable product being administered.
Not suitable for use in patients with contraindications to the specific filler or injectable product (e.g., certain autoimmune diseases, known allergies, bleeding disorders), as described in the product’s instructions for use.
Do not reuse or re-sterilise; re-use may increase the risk of infection, mechanical failure and patient injury.
Use only by appropriately trained and qualified medical practitioners in compliance with local medical and aesthetic practice regulations.

Adverse Effects

Typical injection-related reactions including transient erythema, swelling, tenderness and mild bruising at the entry point or along the injection track.
Occasional haematoma or more pronounced bruising if vessels are damaged during pre-hole needle puncture or cannula passage.
Local pain or discomfort during or after the procedure, usually mild and self-limiting.
As with all dermal filler injections, rare but serious complications such as vascular occlusion, skin necrosis or visual compromise can occur if product is inadvertently injected intravascularly; these risks relate primarily to injection technique and anatomy rather than the cannula itself and must be managed according to established emergency protocols.
Risk of infection if aseptic technique is insufficient or if the device is reused contrary to instructions.

Storage Conditions

Store in a clean, dry environment at controlled room temperature (typically around 15–25°C or as indicated on the packaging).
Protect from direct sunlight, moisture and excessive heat.
Keep in the original packaging until immediately before use to maintain sterility and ensure correct identification.
Do not use after the expiry date printed on the packaging.
Avoid crushing or bending of sterile blisters or pouches to prevent damage to the cannulas or needles.