REGENYAL Idea Super Lips 1x1ml
What is REGENYAL Idea Super Lips?
In summary, Regenyal Idea SUPER Lips is a resorbable medical device (sterile, non-pyrogenic and physiological gel) to be used as a filler for the correction of medium and deep skin sagging of the face and for increasing the volume and contour of the lips. Further, the main component is crosslinked hyaluronic acid of non-animal origin, produced by bacterial fermentation.
* Furthermore, the product is intended for the exclusive use by medical personnel. Do not use for applications other than those indicated in this package insert.
COMPOSITION
Cross-linked hyaluronic acid ………………………………………………. 25 mg / g Phosphate buffer saline, Water for injectable solutions ………………… to taste 1 g
PACKAGE 1x1ml
• package leaflet
• sealed blister containing 1 single-dose / disposable sterile pre-filled syringe
• adhesive strips to be applied on the patient card for product traceability
• 3 needles and 1 cannula
MODE OF ACTION
Moreover, Regenyal Idea SUPER Lips is injected into the skin tissue for the supplementation of the extracellular matrix and the intracutaneous volumetric increase, or for the treatment of skin depressions due to wrinkles and scarring.
INTENDED USE
Further, this product is an implantable medical device manufactured in compliance with Directive 93/42 / EEC MDD, intended for the treatment of imperfections in the following areas of the face:
• nasolabial folds
• peribuccal wrinkles
• acne and facial scars
• glabellar wrinkles
• frontal wrinkles
• areas of the face that require enrichment of the facial tissue (eg. cheeks, chin, cheekbones, lips) with temporary volumetric increase through soft tissue growth.
Moreover, the results depends on the type of skin and the nature of the imperfections, with better results the less evident the nature of the defect is.