CE Marked in accordance with Council Directive 93/42/EEC concerning Medical Devices (and subsequent amendments) for aesthetic/medical use by qualified medical doctors
Manufactured under EN ISO 13485:2016 quality management system for medical devices by Laboratoire Revitacare
Class III Medical Device in the European Union
CE Marked in accordance with Council Directive 93/42/EEC concerning Medical Devices (and subsequent amendments) for aesthetic/medical use by qualified medical doctors
Manufactured under EN ISO 13485:2016 quality management system for medical devices by Laboratoire Revitacare
Produced according to Good Manufacturing Practice (GMP) requirements applicable to medical devices and sterile injectable products
Hyaluronic acid-based hair and scalp mesotherapy
Description
HAIRCARE by Laboratoire Revitacare is a Class III, resorbable injectable medical device for hair and scalp mesotherapy. Each 5 ml vial contains non-crosslinked hyaluronic acid (2 mg/5 ml) combined with a Restructuring Hair Complex of amino acids, zinc and B-group vitamins. Injected by micro-injections into the dermis of the scalp near the hair roots, it hydrates the scalp, improves the quality of hair and scalp, helps anchor the hair follicle, and reduces hair loss while improving hair density, shine, suppleness and vitality in both women and men.
Bnefits
Improves quality of the hair and scalp by restoring hydration
Helps reduce progressive or sudden hair loss by anchoring the hair follicle
Stimulates hair regrowth and increases hair density and thickness
Revitalises hair follicles and strengthens hair roots
Improves structure, softness, shine and overall appearance of the hair
Regulates seborrhea and helps in cases of oily, dandruff-prone scalp
Helps address dry, brittle or dehydrated hair
Supports scalp health and helps reduce inflammation, flaking and peeling
Targets androgenic and stress-related hair loss as part of professional mesotherapy protocols
Indications
Excessive hair loss (progressive or sudden), including androgenic alopecia in men and women
Dry, brittle, dull or dehydrated hair lacking vitality
Hair thinning and reduced hair density
Greasy, seborrheic scalp and dandruff-prone scalp
Premature loss of pigment (early greying) as supportive treatment
General improvement of scalp condition and hair quality as part of aesthetic hair-restoration protocols
Produced according to Good Manufacturing Practice (GMP) requirements applicable to medical devices and sterile injectable products
Amino acids: Ornithine
Trace element: Zinc
B-group vitamins: Vitamin B3 (Niacin)
B-group vitamins: Vitamin B5 (Pantothenic acid)
B-group vitamins: Vitamin B6 (Pyridoxine)
B-group vitamins: Vitamin B8 (Biotin)
B-group vitamins: Vitamin B9 (Folic acid)
B-group vitamins: Vitamin B12 (Cobalamin)
Restructuring Hair Complex / revitalizing complex vehicle (buffered protective medium and excipients as per IFU)
Formulation
Sterile, single-use, non-pyrogenic, resorbable implant for injection
Non-crosslinked hyaluronic acid (2 mg/5 ml) with Restructuring Hair Complex (amino acids, zinc, B vitamins)
Class III Medical Device intended for professional mesotherapy of the scalp
Packaging
Box containing 10 sterile vials x 5 ml (total 50 ml)
Each vial is single-use and for professional medical use only
Product made in France and supplied as a CE-marked Class III Medical Device
Usage
For medical use only; must be injected by a qualified medical doctor with experience in the anatomy and physiology of the scalp.
Inject by multiple micro-injections into the superficial dermis of the scalp near the hair roots, following the official instructions for use and the practitioner’s protocol.
Treat the scalp injection area with appropriate antiseptic prior to the procedure.
The product may be used alone or in combination with other professional hair-restoration protocols as determined by the practitioner.
Injection protocols commonly involve an initial course of multiple sessions (often around 6 treatment sessions) followed by maintenance sessions every few months, tailored to the patient’s needs and the doctor’s clinical judgement.
Do not inject intravascularly. Avoid injection into areas with active infection, inflammation or skin disease.
Before starting treatment, the patient’s medical history and potential contraindications must be evaluated, and the patient should be informed about expected immediate effects and possible side effects.
Only sterile equipment and aseptic techniques should be used. Dispose of any unused product and used vials in accordance with local regulations for medical waste.
Contraindications
Known hypersensitivity or allergy to hyaluronic acid, any amino acid, zinc, B-group vitamins or any other component of the formulation
Presence of skin disease, infection or lesion at the intended injection site on the scalp
History of autoimmune disease or current immunotherapy (as per manufacturer’s medical device guidance)
Any form of bleeding disorders or patients receiving anticoagulant therapy, unless specifically assessed and cleared by a physician in accordance with local guidelines
Pregnant or breastfeeding women
Patients under 18 years of age
General contraindications applicable to injectable mesotherapy as per the product’s instructions for use and local regulations
Adverse Effects
Short-term pain or discomfort at the injection sites
Transient redness (erythema), swelling or oedema at the treated area
Bruising or small hematomas at injection points
Mild itching or tenderness at the injection site
These local reactions are usually mild to moderate and resolve spontaneously within about 72 hours in most cases
Any adverse effects persisting beyond one week or unusual reactions should be reported to the treating practitioner, who should then follow appropriate pharmacovigilance or device-vigilance procedures as per local requirements
Storage Conditions
Store between 2°C and 25–30°C (cool, dry place).
Protect from sunlight, excessive heat and frost.
Do not freeze.
Use only if the primary packaging and vial are intact with no visible damage.
Keep out of the reach of children.
Single-use vials; discard any remaining product after opening.
Duration
Typically used as a course of several mesotherapy sessions (commonly around 6 sessions in an initial treatment cycle) with maintenance sessions scheduled every 3\u20134 months, according to the treating physician\u2019s protocol and the patient\u2019s clinical response.
Onset
Improvement in scalp hydration and reduction in shedding may be observed after the first few sessions, with more visible improvements in hair quality, density and vitality usually becoming apparent after completion of the initial treatment course.
