Belotero Balance (1x1ml)

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

BELOTERO BALANCE is presented in a 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 (0.3×13 mm) and two traceability labels per syringe as well as instructions for use.
Glass syring profiled 1 ml.
Needles 27G 1/2 X2 et 30G X2.

COMPOSITION

• Cross-linked sodium hyaluronate: 22.5 mg.
• Phosphate buffer pH 7 q.s.: 1 ml.

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.