FILLMED® NANOSOFT MICRONEEDLES

FILLMED® NANOSOFT MICRONEEDLES is a sterile, single-use microneedle device designed for intradermal delivery of approved substances. The device is mounted on a standard syringe and features an array of three integrated microneedles, each measuring 0.6 mm in length, allowing for highly controlled and precise injection into the dermal layer. It enables more uniform substance delivery and minimizes the risk of injury or deep tissue penetration compared to conventional needles. It is latex-free and suitable for use across all age groups and skin types when administered by trained medical professionals.

• Designed for intradermal injection of fluids.
  
• Needle length: 0.6 mm
  
• Contains three microneedles in a single unit.
  
• Ensures minimally invasive and pain-reduced application.
  
• Suitable for use with any injectable substance approved for intradermal delivery.

The NANOSOFT® device must be carefully mounted onto a standard syringe and applied using a strict, precise technique. The blue orientation line must face the practitioner at all times.

• Mount NANOSOFT® on the syringe without purging air.
  
• Remove the protective cap.
  
• Purge air and excess fluid, leaving the required dose in the syringe.
  
• Ensure injection site is dry before application.
  
• Position the device at a 45° angle.
  
• Press firmly to form a shallow skin indentation.
  
• Inject slowly, expecting strong resistance.
  
• A white wheal (bleb) will appear post-injection.
  

NANOSOFT® is intended for intradermal injections of approved substances or medications. It allows precise dermal administration in aesthetic and dermatological procedures.

Indications:

• Intradermal injection of mesotherapy products, vitamins, peptides, and HA-based treatments.
  

Contraindications:

• Avoid use on abraded skin, open wounds, cuts, scars, rashes, or infected or compromised skin.
  

Side effects:

• Local reactions such as edema, erythema, and discoloration.
  
• Possible micro-bleeding that resolves naturally.
  
• Rare instances of localized infections.

The device itself is composed of three microneedles, each 0.6 mm in length, integrated into a sterile single-use head.

• Three stainless steel microneedles.
  
• Needle length: 0.6 mm
  
• Latex-free design.
  
• Sterilized with ethylene oxide (EtO).

Each unit is provided as a single-use, sterile device packaged in a soft blister pack.

• 1 × NANOSOFT® microneedle device per pack.
  
• Blister pack is EtO sterilized.
  
• Labeled with batch number, expiration date, and storage conditions.

The device is well-tolerated, but minor adverse events can occur, typically related to the injected substance rather than the device itself.

• Common: redness (erythema), swelling (edema), skin discoloration.
  
• Device-related: micro-bleeding that is self-limiting.
  
• Rare: localized infections at the injection site.

Proper storage ensures device sterility and performance integrity.

• Store at temperatures between -10°C and 30°C (14°F to 86°F).
  
• Keep in a dry place, away from sunlight.
  
• Do not use if the blister is damaged or opened.
  
• Do not reuse or resterilize.
  
• Dispose in accordance with local sharps waste regulations.