mesofiller

Hyaluronic acid filler

Product descriptionmesofiller is a sterile, injectable and resorbable medical device

based on cross-linked hyaluronic acid

to be used as a temporary filler for the correction of aesthetic concerns such as wrinkles or depressions.

t allows firming the tissues and filling intradermal spaces and intercellular matrix.

mesofiller

Hyaluronic acid filler

mesofiller medium25 mg/ml (2,5%)

Concentrations

mesofiller soft20 mg/ml (2%)

fine lines and wrinkles in the periocular or perilabial area.

deep wrinkles, nasolabial fold, cheeks and lips.

mesofiller

Hyaluronic acid filler

Packaging contents

1 * 1ml prefilled, graduated, disposable and sterile glass syringe

1 information pamphlet

1 blister

2 sterile 27G½ needles 2 traceability adhesive labels

mesofiller

Hyaluronic acid filler

Top quality crosslinking technique

Crosslinking agent: BDDE

The crosslinking balance is essential for maintaining both the duration and the biocompatibility of the HA filler.There are mainly two different crosslinking agents: DVS (divinyl sulfone) and BDDE (butanediol diglycidyl ether).BDDE is considered as a higher end product that allows an easier and more universal filling.

Crosslinking agent residues: < 50 ppb (=0.05 ppm)

Probably one of the purest HA in the market obtained thanks to an advanced purification techniques.Standard fillers use to carry around 50 ppm residues (1’000 times more)

mesofiller

Hyaluronic acid filler

Technical data

One-phase

Origin: biotechnogical (non-animal; produced via bacterial fermentation)

Molecular weight: 2.4 - 4 MDa (raw material)

Dynamic viscosity: mesofiller soft: 170 Pa-s mesofiller medium: 250 Pa-s

pH: 6.00 - 7.50

Endotoxins: < 0.5 EU/ml (LAL test- kinetic chromogenic method)

Steam sterilised

mesofiller

Hyaluronic acid filler

Regulatory context & quality guarantees

MEDICAL DEVICE CE

Produced according to the ISO 9001, ISO 13485and GMP standard (Good Manufacturing Practice).

Biocompatibility studies performed according to the ISO 10993 guide lines.