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Informations for patients PRECISE - HA Fillers

WHY PRECISE - HA FILLERS?

PRECISE-HA FILLERS portfolio

It is the diversification of the formulas of each reference

PRECISE-HA FILLERS products are unique integrated solutions [gel + delivery system] on the market, jointly developed by SYMATESE research. At the heart of the products, a proprietary technology created by our researchers and resulting from our expertise in hyaluronic acid: C-HA.PURE TECHNOLOGY by SYMATESE.

A technology that makes it possible to develop highly targeted products, each dedicated to an indication of the face. Each product PRECISE-HA Filler SOFTEN, LIPS, EYE, SMOOTH & SCULPT has specific characteristics and responds exactly and effectively to the needs of the area concerned.

PRECISE-HA Filler
SOFTEN
PRECISE-HA Filler
LIPS
PRECISE-HA Filler
EYE
PRECISE-HA Filler
SMOOTH
PRECISE-HA Filler
SCULPT
INTENDED PURPOSE
Modification of the skin anatomy and facial appearance. (Non-medical purpose)
INDICATIONS
Indicated to correct nasolabial folds and perioral lines
Indicated to correct the volume and the shape of the lips
Indicated to correct infraorbital hollows
Indicated to correct nasolabial folds
Indicated to restore cheek volume loss
TISSUES LEVEL OF INJECTION
Dermis to hypodermis
Dermis, hypodermis and labial mucosa
Dermis to hypodermis and supraperiosteal
Dermis to hypodermis
Hypodermis and supraperiosteal

C-HA.Pure Technology by SYMATESE™

First generation cold technology

COLD TECHNOLOGY by SYMATESE based on the following key elements:

  • An exclusive COLD temperature cross-linking process that induces less HA transformation1
  • As little chemistry as possible for SAFE and LASTING products with natural effects.
  • Chains 4 times2 more preserved in comparison with standard technologies

HIGH TEMPERATURE

TYPICAL CROSSLINKING

COLD TECHNOLOGY

COLD TECHNOLOGY by SYMATESE

All you need to know on PRECISE-HA FILLERS

Description

The gel of each PRECISE-HA FILLERS Product is sterile, bioabsorbable, colorless made of crosslinked hyaluronic acid, non-crosslinked hyaluronic acid from non-animal sources and containing lidocaine hydrochloride 3 mg/mL.

Each PRECISE-HA FILLERS Product contains local anesthetic lidocaine in order to reduce pain during and post-injection procedure.

The gel is supplied in a 1 mL plastic syringe which is the sterile barrier system. The gel is sterilized by moist heat (air/steam mixture). The syringe containing the sterile gel is assembled with plunger rod and finger rest and corresponds to the injection device. The needles supplied are sterilized by radiation.

Each PRECISE-HA FILLERS Product is available in boxes of one or two protective blister(s) including an injection device and two ultra-thin wall needles.The injection device and the needles are for single use only.

Intended purpose

PRECISE-HA dermal fillers are intended for non-medical use only.

PRECISE-HA dermal fillers are intended to modify the skin anatomy and facial appearance.

Indications

PRECISE-HA Filler
SOFTEN
PRECISE-HA Filler
LIPS
PRECISE-HA Filler
EYE
PRECISE-HA Filler
SMOOTH
PRECISE-HA Filler
SCULPT
– Indicated to correct nasolabial folds and perioral lines.
– Injected into dermis to hypodermis.
– Indicated to correct the volume and the shape of the lips.
– Injected into dermis, hypodermis and labial mucosa.
– Indicated to correct infraorbital hollows
– Injected into hypodermis and supraperiosteal
– Indicated to correct nasolabial folds.
– Injected into dermis to hypodermis.
– Indicated to restore cheek volume loss.
– Injected into hypodermis and supraperiosteal

Contraindications

Each PRECISE-HA FILLERS Product is contraindicated in:

  • Minors.
  • Subjects with a known allergy to hyaluronic acid, lidocaine or amide local anesthetics.
  • Subjects with porphyria.
  • Subjects with an autoimmune disorder, or using an immunosuppressant medication.
  • Pregnant or breastfeeding women.
  • Subjects with inflammation, infection or cutaneous disorders at the treatment site or nearby.
  • Subjects with bleeding disorders or in subjects receiving thrombolytic or anticoagulant treatment
  • Areas other than those recommended
    • PRECISE-HA Filler SOFTEN is injected into dermis, hypodermis
    • PRECISE-HA Filler LIPS is injected into dermis, hypodermis and labial mucosa
    • PRECISE-HA Filler EYE is injected into hypodermis and supraperiosteal
    • PRECISE-HA Filler SMOOTH is injected into dermis to hypodermis
    • PRECISE-HA Filler SCULPT is injected into hypodermis and supraperiosteal
 

Targeted population

Each PRECISE-HA FILLERS Product is used in adult subjects, excluding pregnant and breastfeeding women. Each PRECISE-HA FILLERS Product is not to be used in persons who are less than 18 years old.

Intended user

Each PRECISE-HA FILLERS Product shall only be administered by appropriately trained healthcare professionals who are qualified or accredited in accordance with national law in injection techniques for the modification of facial anatomy.

Environment of use

Each PRECISE-HA FILLERS Product is intended to be used in hospital environment or private medical offices.

What can you expect regarding performance and lifetime?

Each PRECISE-HA FILLERS Product acts by adding volume to the tissue, thereby restoring the skin contours and the volume and shape of the face to the desired level. The volume and lifting capacity originate from the ability of the crosslinked hyaluronic acid gel to hold its shape in the tissue, thus maintaining over time the volume and projection obtained at injection. The duration of effect depends on the area treated and the depth of injection, and may vary from one subject to another.

Each PRECISE-HA FILLERS Product contains local anesthetic lidocaine in order to reduce pain during and post-injection procedure.

PRECISE-HA Filler
SOFTEN
PRECISE-HA Filler
LIPS
PRECISE-HA Filler
EYE
PRECISE-HA Filler
SMOOTH
PRECISE-HA Filler
SCULPT
On average, with 1,2 mL injected into the nasolabial folds and 0.5 ml injected into lip fine lines, in one session, 93% of subjects are noticeably improved at 9 months (clinical study results obtained with the Global Aesthetic Improvement Scale)3.

The expected lifetime for PRECISE-HA Filler
SOFTEN
is 12 months.
On average, with 1 mL injected into the lips in one session, 93% of subjects are noticeably improved at 9 months (clinical study results obtained with the Global Aesthetic Improvement Scale)3.

The expected lifetime for PRECISE-HA Filler
LIPS
is 12 months.
On average, with 0.5 mL injected per infraorbital hollow in one session, between 68.4 and 71.9% of subjects are noticeably improved at 9 months (clinical study results obtained with the Global Aesthetic Improvement Scale)6 .

The maximum expected lifetime for PRECISE-HA Filler
EYE
is 12 months.
On average, with 0.9 mL injected per nasolabial fold in one session, 82% of subjects are noticeably improved at 9 months (clinical study results obtained with the Global Aesthetic Improvement Scale)4.

The expected lifetime for PRECISE-HA Filler
SMOOTH
is 9 months.
On average, with 1,1 mL injected per cheek in one session, between 58.2 and 60% of subjects are noticeably improved at 9 months (clinical study results obtained with the Global Aesthetic Improvement Scale)5.

The expected lifetime for PRECISE-HA Filler
SCULPT
is 15 months.

Additional information

Considering the composition of each PRECISE-HA FILLERS Product, there is no warning, precaution and/or measure to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures. The supplied needles must not be used under MRI.

1 FASY MDR 23-031 V0.

2 FASY 19-036 V0.

3 Internal data: prospective study evaluating lips enhancement and perioral lines correction with FASY hyaluronic acid dermal fillers (CLIN 1901).

4 Internal data: a prospective, single center, comparative, double blinded clinical study evaluating the efficacy of a new dermal filler on nasolabial folds correction (CLIN 1701).

5 Internal data: an interventional prospective study evaluating the safety and performance of FASY hyaluronic acid dermal filler in correction of cheeks volume loss (CLIN 1907).

6 Internal data : an interventional prospective study evaluating the safety and performance of FASY hyaluronic acid dermal filler in correction of infraorbital hollows (CLIN 1902). 

Informations for patients

The following document describes the regulatory content of the PRECISE-HA dermal fillers Patient Page in order to answer to the article 18 of the Regulation 2017/745 concerning the Implant Card and the information to be supplied to the patient with an implanted device.

Composition of the product range

MAIN INGREDIENTS
PRECISE-HA Filler
SOFTEN
PRECISE-HA Filler
LIPS
PRECISE-HA Filler
EYE
PRECISE-HA Filler
SMOOTH
PRECISE-HA Filler
SCULPT
Total Sodium Hyaluronate
20 mg/g
20 mg/g
15 mg/g
22 mg/g
23 mg/g
Lidocaine hydrochloride
3 mg/g
3 mg/g
3 mg/g
3 mg/g
3 mg/g

References and units per box

DESCRIPTION
REFERENCE
Box composition
PRECISE-HA Filler SOFTEN
(Indicated to correct nasolabial folds and perioral lines)
401005
2 blisters / box including 1 injection device and 2 needles (2 x 30G½”) per blister
PRECISE-HA Filler LIPS
(Indicated to correct the volume and the shape of the lips)
401010
2 blisters / box including 1 injection device and 2 needles (2 x 30G½”) per blister
PRECISE-HA Filler EYE
(Indicated to correct infraorbital hollows)
401012
2 blisters / box including 1 injection device and 2 needles (2 x 30G½”) per blister.
PRECISE-HA Filler SMOOTH
(Indicated to correct nasolabial folds)
401001
2 blisters / box including 1 injection device and 2 needles (1 x 30G½” and 1 x 27G½) per blister
PRECISE-HA Filler SCULPT
(Indicated to restore cheek volume loss)
401001
2 blisters / box including 1 injection device and 2 needles (2 x 27G½) per blister

Products must be stored between +2°C and +25°C. Protect the gel from sunlight.

After opening, discard any unused material according to the institutional policies.

Manufacturers information

Legal Manufacturer of the injection device/ Procedure Pack Producer

SYMATESE SAS

ZI Les Troques

69630 Chaponost

France

Tel.: +33 (0) 4 78 56 72 80

Fax: +33 (0) 4 78 56 00 48

Legal Manufacturer of the needles:

TSK LABORATORY, JAPAN

1510-1 Soja-Machi, Tochigi-shi,

Tochigi-ken, 328-0002 – Japan

EC Representative:

EMERGO EUROPE

Prinsessegracht 20

2514 AP The Hague

The Netherlands

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