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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 | |
COLD TECHNOLOGY by SYMATESE based on the following key elements:
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 and improve comfort during and post-injection.
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.
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.
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 |
 |  |  |  |  |
Each PRECISE-HA FILLERS Product is contraindicated in:
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.
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.
Each PRECISE-HA FILLERS Product is intended to be used in hospital environment or private medical offices.
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. The maximum expected in-situ lifetime for Each PRECISE-HA FILLERS Product is 18 months.
Each PRECISE-HA FILLERS Product contains local anesthetic lidocaine in order to reduce pain and improve comfort during and post-injection.
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 in the nasolabial folds and 0.5 ml injected in lip fine lines, in one session, between 90 and 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 in the lips in one session, between 90 and 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 ring 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 18 months.
|
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).
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.
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 |
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.
SYMATESE SAS
ZI Les Troques
69630 Chaponost
France
Tel.: +33 (0) 4 78 56 72 80
Fax: +33 (0) 4 78 56 00 48
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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