Fillmed Nanosoft Microneedles 0.6mm
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
FILLMED NANOSOFT® is a single-use microneedle medical device, not an injectable product: it incorporates three 0.6 mm silicon microneedles that attach to a conventional syringe in order to deposit the product in the dermis at a standardised depth. FILLMED developed it for the areas where the classic needle is most uncomfortable or most prone to haematoma — eye contour, neck and décolletage — and integrates it into the protocols for NCTF® 135HA and M-HA® 10. Box of 30 units.
- Microneedles 3 of silicon
- Length 0.6 mm
- Contents 30 units
- Use single use
- Compatible NCTF® 135HA · M-HA® 10
Construction and principle of operation
Head with three silicon microneedles 0.6 mm in length. The manufacturer describes the microtips as approximately three times smaller than a standard injection needle. By dividing the flow between three outlet points, the device deposits the product homogeneously at a constant depth instead of depending on the operator's angle and pressure.
Standardised depth. The fixed 0.6 mm geometry confines the deposit to the dermis. In an ex vivo study the manufacturer documents that the product remains intact in the dermis without diffusion into the hypodermis, unlike the conventional needle.
Papule formation. Each injection point generates a visible papule which, according to the manufacturer, is usually reabsorbed within 24 hours.
Universal attachment: the device fits conventional syringes, which allows it to be used with different working volumes.
Compatibility and positioning
NANOSOFT® is integrated by the manufacturer into the protocols for two products in its catalogue:
| NCTF® 135HA | Polyrevitalising solution with free HA 5 mg/ml and a complex of 59 active ingredients. Protocol with NANOSOFT® for the eye contour, neck and décolletage |
|---|---|
| M-HA® 10 | Free non-cross-linked HA 10 mg/ml. Protocol with NANOSOFT® in the same delicate areas |
What it is not: NANOSOFT® is not an injectable product and contains no active substance whatsoever. It is an administration accessory. Nor is it a percutaneous microneedling device of the dermaroller or dermapen type: it does not work by repeated puncture of the surface, but by discrete intradermal injection through the syringe to which it is attached.
Intended use: the manufacturer positions it as an alternative to the classic injection needle in areas of thin, highly vascularised skin.
Treatment areas and technique
Areas envisaged by the manufacturer:
- Eye contour — eyelid and crow's feet
- Neck
- Décolletage
Technique:
- Disinfect the skin before the procedure.
- Draw the product up into the syringe with the corresponding drawing-up cannula and attach the NANOSOFT® head.
- Apply the head perpendicular to the skin and perform multiple intradermal injections spaced 1 to 1.5 cm apart, forming visible papules. In the protocol documented by the manufacturer, approximately 0.05 ml is used per injection point.
- As regards volumes, number of sessions and intervals, follow the protocol of the product injected, not that of the device.
Manufacturer's comparative data (study published in the Journal of Cosmetic Dermatology, 2024; 40 subjects; NCTF® 135HA administered with NANOSOFT® versus a classic 32G × 4 mm needle, 3 sessions on days 0, 21 and 42): pain during injection approximately 2 points lower with NANOSOFT® on the face and neck; adverse events of lower intensity and with a mean duration of 2.4 ± 2.1 days versus 3.1 ± 2.8 days with the classic needle; no serious adverse events.
Technical data
| Manufacturer | Laboratoires FILL-MED, France |
|---|---|
| Product type | Microneedle device for intradermal injection — accessory, without an active substance |
| Microneedles | 3, of silicon |
| Length | 0.6 mm |
| Attachment | Fits conventional syringes |
| Material | Latex-free |
| Presentation | Box of 30 units |
| Reuse | Single use — discard after each patient |
| Classification | Medical device with CE marking |
| Use | Qualified healthcare professionals only |
Storage, hygiene and pack contents
- Contents: 30 sterile NANOSOFT® devices.
- Strictly single use. Do not reuse between patients or between areas of the same patient once sterility has been compromised. Do not resterilise: the silicon head is not designed to withstand a sterilisation cycle.
- Check the integrity of the individual pack before each use; do not use the device if the pack is open or damaged.
- Dispose of in a sharps waste container in accordance with the regulations in force.
- Storage: in a clean, dry place, protected from direct light. Do not use after the expiry date shown on the packaging.
Warnings and precautions for use
Device for professional application only. Its use presupposes training in intradermal injection technique.
Disinfect the skin before the procedure. Do not apply to skin with active infection, inflammation or lesion in the treatment area.
The applicable clinical contraindications, warnings and precautions are those of the product administered through the device: consult the instructions for use of that product before treatment.
Also consult the instructions for use included in the device packaging.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the official documentation of Laboratoires FILL-MED (NANOSOFT® product data sheet, treatment protocol guide and clinical publication circulated by the manufacturer). This data sheet does not replace the instructions for use accompanying the product.