Description & Composition: Cristal Highest Purity Dermal Filler is a resorbable medical device, composed of Hyaluronic Acid, derived from a non-animal source.

Cristal is a sterile, nonpyrogenic, viscoelastic, hydrated, insoluble, biologically compatible (non-immunnogenic, non-inflammatory, non-toxic), crystal-clear gel implant, composed of a cross-linked derivative of the natural hyaluronic acid molecule.

Note: ENDOTOXINS < 0.001 EU/mg. Specification of the latest European Pharmacopeia (5th EDITION), require for Hyaluronic Acid Gels for use intradermal, intraarticular, intraocular endotoxins less than 0.05 EU/mg

Applications/Indications: Common areas of treatment:

1. Forehead Lines (Worry lines)
2. Glabellar Folds (Frown lines)
3. Periorbital Lines (Crow's feet)
4. Nasolabial Folds (Smile lines)
5. Perioral Lines (Vertical lip lines)
6. Oral Commissures (Marionette lines)
7. Vermilion (Lip) Boarder & Lip Region
8. Face & Acne Scars

Side Effects Contraindications: Cristal may not be administered with patients with:

1. Known susceptibility to keloid or hypertrophic scarring
2. Auto - immune disorders or under immunotherapy
3. Multiple severe allergies
4. Active inflmmatory or infection process
5. Acute or chronic skin disease in or near the injection sites
6. Coagulation defects or under anti-coagulation therapy
7. Sensitivity to hyaluronic acid

Cristal is contraindicated for use in breast enlargement, or for implantation into bone, tendon, ligament, or muscle and must not be injected into blood vessels.

Cristal must not be mixed with other injectable implants. Avoid using aspirin, non-steroidal anti-inflammatory medications, St. John's Wort, or High doses of Vitamin E supllements prior to treatment, as these may cause bruising and bleeding, in the treated area.
The treated area should not be exposed to excessive heat (e.g. Sun or UV tanning, laser, IPL) or extreme cold within the resolving period (until any initial swelling or redness has resolved)

Directions For Use
1. Inform patient of the indications and contraindications.
2. Pain relief or local anesthesia, is not usually needed. For lips enhancement, nerve block may be used.
3. The area to be treated should be thoroughly disinfected.
4. Inject Cristal in the superficial to mid/deep dermis, depending on the lesion being corrected. There are 2 effective injecting techniques:
4.1 Linear Threading Technique (or Tunneling Technique): Involves insertion of the full length of the needle intracutaneously, followed by injection of the product, while gently withdrawing the needle (Retograde Technique).
4.2 Serial Puncture Technique (Multipuncture Technique): A series of injections creates a smooth, continuous line or surface.
5. At the end, apply a gentle massage of the treated area to comform to the contour of the surrounding tissue.
6. Best results are obtained in areas where the defect can be manually stretched to the point where it vanices. No overcorrection is necessary.
7. After 4 weeks, one or more additional injections, may be necessary, to achieve and maintain the desired results. Optimal results can be maintaned by 6-12 months repetition.
8. Cristal is only permitted to be used by trained Medical Professionals and in accordance with local legislations.

How Supplied & Storage Conditions: Cristal is supplied as a 1.0ml volume in a single-use syringe with a needle-locking device and a cap assembled in a blister pack and two sterile, 30 G needles. IF PACKAGE IS OPENED OR DAMAGED DO NOT USE. DO NOT RESTERILIZE. DO NOT FREEZE OR EXPOSE TO EXTREME HEAT. STORE BETWEEN 2-25C.

IMPORTANT NOTE: Each product is accompanied with detailed illustrated instructions for use and must be read thoroughly before treatment.

Cristal is made in Germany, according to ISO13485:2003 and MDD 93/42/EEC, Annex II (Class III), CE Certified, Registered as Medical Devices in E.U. and known as Dermal Fillers of Highest Quality.