FILLMED NANOSOFT MICRONEEDLES 0.6 mm

FILLMED

Injection accessories / microneedle devices

Microneedle device for controlled intradermal injections (0.6 mm, 3-cone array)

CE Marked sterile medical device for intradermal injection (CE conformity marking indicated on IFU and labelling).
Manufactured by NanoPass Technologies Ltd., an ISO 13485–certified medical device company specialising in microneedle Based intradermal delivery platforms (e.g., MicronJet).
Latex Free, non Pyrogenic, single Use device sterilised with ethylene oxide (EtO), compliant with relevant EU/EEA and UK medical device regulations for Class I/IIa devices (classification according to local requirements).
Distributed in collaboration with Laboratoires FILLMED for aesthetic medicine indications, and used in accordance with regulatory approvals for intradermal delivery devices in multiple jurisdictions.

CE Marked sterile medical device for intradermal injection (CE conformity marking indicated on IFU and labelling).
Manufactured by NanoPass Technologies Ltd., an ISO 13485–certified medical device company specialising in microneedle Based intradermal delivery platforms (e.g., MicronJet).
Latex Free, non Pyrogenic, single Use device sterilised with ethylene oxide (EtO), compliant with relevant EU/EEA and UK medical device regulations for Class I/IIa devices (classification according to local requirements).
Distributed in collaboration with Laboratoires FILLMED for aesthetic medicine indications, and used in accordance with regulatory approvals for intradermal delivery devices in multiple jurisdictions.

Microneedle device for controlled intradermal injections (0.6 mm, 3-cone array)

Description

FILLMED Nanosoft Microneedles 0.6 mm is a sterile, single-use microneedle device designed for precise, controlled intradermal injection of liquid substances such as FILLMED NCTF 135 and NCTF 135 HA. The device mounts onto a standard syringe via a Luer-lock connector and features an integral array of three ultra-fine silicone micro-cones, each 0.6 mm in length, which standardises injection depth into the dermis. This technology enables nearly painless, flat and consistent intradermal delivery with minimal bruising, making it particularly suitable for delicate treatment areas like the eyelids, crow’s feet, periorbital and perioral zones, neck and décolleté. Nanosoft is CE-marked, latex-free and classified as a sterile medical device for professional use only.

Bnefits

Provides controlled, standardised intradermal injection depth (0.6 mm) for reliable delivery
Three ultra-fine silicone micro-cones are approximately three times smaller than a standard injection needle, enhancing patient comfort
Nearly painless, flat and consistent intradermal delivery, improving patient tolerance of treatments
Minimises bruising and visible puncture marks, especially in sensitive facial and neck areas
Optimises diffusion of injected products: small papules (blebs) form immediately and typically disappear within 24 hours as product spreads
Ideal for use with FILLMED NCTF 135 and NCTF 135 HA polyrevitalising solutions and other substances approved for intradermal injection
Compatible with standard Luer-lock syringes, making integration into existing clinical workflows simple
Single-use sterile device reduces risk of cross-contamination and infection when used according to IFU
Blue orientation line helps practitioners maintain correct positioning and injection angle
Technical design improves reproducibility of mesotherapy and skin quality treatments on face, neck and décolleté

Indications

Intradermal injection of any substance or medicinal product approved for delivery via the intradermal route (per official IFU)
Precise intradermal delivery of FILLMED NCTF 135 and NCTF 135 HA polyrevitalising solutions for skin rejuvenation
Treatment of delicate and difficult-to-treat areas such as eyelids, crow’s feet, periorbital and perioral regions
Mesotherapy and skin-quality procedures on the face, neck and décolleté where standard needles may cause more discomfort or bruising
Fine-line and superficial wrinkle treatments in thin or sensitive skin zones using suitable intradermal products
Any aesthetic or dermatologic procedure requiring controlled, shallow intradermal injections with minimal trauma, when a microneedle device is appropriate

Composition

Microneedle array: integral array of 3 hollow microneedles (micro-cones), each 0.6 mm in length, made of medical-grade silicone
Gauge / size: approximately 34G equivalent (super-fine microneedles)
Connector: standard Luer-lock hub for mounting on compatible syringes
Device characteristics: sterile, non-pyrogenic, latex-free, single-use
Sterilisation method: ethylene oxide (EtO) sterilised, as indicated on the blister packaging and IFU
Supplied as an individually packed microneedle device in a soft sterile blister

Formulation

Mechanical medical device (no medicinal active ingredient) for intradermal delivery of liquid substances
Microneedle-based injection system designed to be mounted on a standard syringe like a conventional needle
Three-cone, 0.6 mm microneedle geometry engineered to create shallow intradermal wheals (blebs) with each injection
Designed for virtually painless, controlled intradermal administration with improved precision and reproducibility compared to standard needles

Packaging

Each NANOSOFT device is supplied as a single sterile microneedle unit in an individual soft blister (single sterile barrier system), EtO sterilised
Commercial aesthetic packs typically contain 30 x 0.6 mm Nanosoft microneedles per box (30 pcs), labelled as FILLMED Nanosoft Microneedles 0.6 mm
Blister and outer box carry essential labelling including lot/batch number, use-by/expiry date, temperature limits, CE marking, manufacturer details and UDI
Packaging clearly marked as single-use, non-resterilisable, and to be discarded as sharps after use

Usage

For professional use only: the device is intended solely for single use by trained healthcare professionals familiar with intradermal injection techniques.
Draw the desired liquid substance (e.g., NCTF 135 HA or other intradermal-approved solution) into a standard syringe without purging.
Open the soft blister and firmly connect the Nanosoft microneedle to the Luer-lock syringe hub.
Remove the protective plastic cover, then purge air and excess fluid, leaving the required injection volume in the syringe.
Ensure the injection site is cleansed, disinfected and completely dry prior to injection.
During injection, hold the syringe flanges between thumb and fingers; keep the blue orientation line facing the practitioner at all times.
Stretch the skin downward or laterally throughout the injection to stabilise the area.
Insert the device at approximately a 45° angle, pressing into the skin until a shallow indentation is formed, indicating appropriate intradermal placement.
Inject slowly; strong resistance is expected due to intradermal delivery. A small white wheal (bleb/papule) should form at the injection point, confirming intradermal deposition.
Apply multiple standardised papules according to the clinical protocol and product manufacturer’s recommendations for the injected substance.
After treatment, dispose of the used Nanosoft device immediately in an approved sharps container. Do not recap, reuse, or attempt to resterilise.
Advise patients regarding standard post-injection care for intradermal treatments (e.g., avoid rubbing the area, intense heat or cold, and follow specific advice related to the injected product).
Always follow the latest official Nanosoft Microneedles Instructions for Use (IFU) provided by NanoPass/FILLMED, as well as the IFU of the injected product and local clinical guidelines.

Contraindications

Do not use on skin abrasions, open wounds, cuts or scars at the intended injection site (per IFU).
Do not use on rashes, skin infections or any area of damaged, diseased or compromised skin (e.g., active dermatitis, severe inflammatory conditions) at the injection site.
Contraindications and restrictions of the injected substance (e.g., NCTF 135 HA or other drugs) must also be strictly observed; if the product to be injected is contraindicated in a given patient or condition, Nanosoft must not be used for that indication.
Not to be used by non-professionals; the device is intended exclusively for trained healthcare professionals.
Do not reuse the device under any circumstances, as reuse may lead to infection or other illness/injury.
Do not use if the sterile blister packaging is open, damaged or compromised, or if the device appears broken or defective.
Standard contraindications for intradermal injection procedures (e.g., certain coagulation disorders, uncontrolled systemic disease) apply and should be assessed by the treating clinician.

Adverse Effects

Localised oedema (swelling), erythema (redness) and transient discolouration at the injection site have been observed; these are most often related to the injected substance rather than the Nanosoft device itself (per IFU).
Small risk of micro-bleeding at injection points (tiny blood droplets that are self-limiting and typically cease within normal clotting time).
Rare potential for localised infection at the injection site if aseptic technique or post-treatment care is inadequate.
As with any intradermal injection, there may be transient tenderness, mild discomfort or small papules that usually resolve within 24 hours as the product diffuses.
Any serious, unexpected or persistent adverse event should be evaluated by a healthcare professional and reported to the manufacturer and competent regulatory authorities according to medical device vigilance requirements.

Storage Conditions

Store Nanosoft Microneedles at a temperature between -10°C and 30°C (14–86°F), as specified in the IFU.
Keep devices in their original outer packaging and individual soft blisters until use to maintain sterility.
Protect from excessive heat, moisture and direct sunlight; keep dry.
Do not use the device if the blister is open, torn or otherwise damaged.
Do not resterilise. Single sterile barrier system sterilised using ethylene oxide (EtO); intended strictly for single use.
Dispose of used or unused devices in accordance with national and institutional sharps and medical waste guidelines.

Duration

Not fixed for the device itself; Nanosoft Microneedles are used per session during intradermal procedures. Overall treatment duration and number of sessions depend entirely on the protocol of the injected product (e.g., NCTF 135 HA mesotherapy courses typically spanning several sessions over weeks to months).

Onset

Device-related effects are immediate in terms of intradermal delivery (papules/blebs form at injection). Clinical onset and duration of therapeutic or aesthetic benefits depend on the substance injected (such as NCTF 135 HA) and the specific treatment protocol, rather than the Nanosoft device itself.