BATCH OF 20 BELOTERO BALANCE LIDO (1x1ml) MERZ AESTHETICS

BELOTERO BALANCE LIDO (1x1ml) MERZ AESTHETICS

MEDICAL USE. Class III medical devices. To guarantee the success of the treatment, the practitioner must have undergone specific training on injection techniques aimed at restoring facial volumes. Good knowledge of the anatomy and physiology of the site to be treated is required. This treatment should be given under appropriate aseptic conditions.

DESCRIPTION

BELOTERO BALANCE implant (Injectable hyaluronic acid) package is provided sterile. BELOTERO BALANCE is a prescription injection that is approved to temporarily smooth out and fill in moderate to severe nasolabial folds (the folds or wrinkles that go from the side of the nose to the corner of the mouth). BELOTERO BALANCE is a sterile, bioresorbable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel device. BELOTERO BALANCE is a bacterially fermented, injectable, hyaluronic-acid-based dermal filler. After extraction and purification, hyaluronic acid manufactured from streptococcal cultures is cross-linked with a binding agent 1,4-butanediol diglycidyl ether (BDDE) in two consecutively executed reactions and reconstituted in a physiologic buffer at pH 7 and concentration of 22.5 mg/mL.

PRESENTATION

• 1 ml sterile glass syringe for single use, sterilized by moist heat.
• Each box contains two sterile CE-marked hypodermic needles of 27G1/2 (0.4x13mm) and 30G1/2 (0.3x13 mm) and two traceability labels per syringe as well as instructions for use.
• Needles 27G 1/2 X2 et 30G X2.

COMPOSITION

Cross-linked sodium hyaluronate 22.5 mg + 0.3% of lidocaine hydrochloride.

• Phosphate buffer pH 7 q.s.: 1 ml.
• 0.3% of lidocaine hydrochloride.

INTENDED USE/ INDICATION

• BELOTERO BALANCE is an injectable resorbable implant indicated to fill moderate facial wrinkles and folds as well as for lip enhancement.
•  It is also suitable for correction of facial atrophic scars.

ZONES OF INJECTION

BELOTERO BALANCE is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.

• Moderate perioral lines.
• Nasogenous wrinkles.
• Glabella folds.
• Folds of bitterness.
• Lips (contours).
• Commissures of the lips.