PLURYAL BOOSTER (1x1ml)
Pluryal
Aesthetic / cosmetic injectableHyaluronic acid antioxidant skin booster
Certifications
- CE Marked medical device for intradermal injection within the European Community
- Manufactured in compliance with ISO 13485 quality management standards for medical devices
- Manufactured under GMP (Good Manufacturing Practice) conditions
- Gel preparation performed under clean Room conditions according to EN ISO 14644
- Biocompatibility assessed in line with EN ISO 10993 guidelines
- Very low levels of residual BDDE (cross Linking agent) and controlled protein and endotoxin levels, within specifications compatible with international regulatory expectations
- CE Marked medical device for intradermal injection within the European Community
- Manufactured in compliance with ISO 13485 quality management standards for medical devices
- Manufactured under GMP (Good Manufacturing Practice) conditions
- Gel preparation performed under clean Room conditions according to EN ISO 14644
- Biocompatibility assessed in line with EN ISO 10993 guidelines
- Very low levels of residual BDDE (cross Linking agent) and controlled protein and endotoxin levels, within specifications compatible with international regulatory expectations
Hyaluronic acid antioxidant skin booster
Description
PLURYAL BOOSTER (1x1ml) is a monophasic cross-linked hyaluronic acid (HA) skin booster with added glycerol and antioxidants, developed by MD Skin Solutions within the Pluryal range. Injected into the superficial dermis, it is designed to restore hydration, density and glow, improve firmness and elasticity, and correct fine lines on the face, neck, décolletage and hands. With an HA concentration of 18 mg/ml and glycerol 20 mg/ml, plus very low protein and endotoxin levels and a high molecular weight (≈3 million Daltons), PLURYAL BOOSTER provides deep, long-lasting skin hydration and antioxidative protection, helping to reduce enlarged pores, acne scars and signs of fatigue while delivering smoother, more radiant and younger-looking skin.
Bnefits
- Restores hydration, density and glow in the superficial dermis
- Rehydrates and redensifies the skin for a firmer, fresher appearance
- Improves skin tone, elasticity and overall skin quality
- Smooths fine lines and superficial wrinkles (e.g. crow’s feet, smoker’s lines)
- Reduces enlarged pores and helps improve the appearance of acne scars
- Provides deep, long-lasting hydration thanks to 18 mg/ml HA and 20 mg/ml glycerol
- Antioxidant skin booster effect to combat environmental and lifestyle-related skin aging
- Monophasic, stabilized HA formulation for better resistance to degradation and longer duration
- Natural-looking, immediate improvement in skin radiance with minimal downtime
- High purity profile with trace protein and low endotoxin levels, supporting safety and tolerability
Indications
- Loss of glow and firmness
- Loss of skin structure and density
- Dehydrated or devitalised skin
- Fine lines and superficial wrinkles (crow’s feet, perioral lines, fine cheek lines)
- Enlarged pores and mild acne scarring
- Early signs of photoageing and environmental skin damage
- Maintenance of skin quality after other aesthetic treatments (e.g. fillers, lasers, mesotherapy)
Composition
- Monophasic cross-linked hyaluronic acid 18 mg/ml (non-animal, bacterial origin)
- Glycerol 20 mg/ml (stabilising polyalcohol for hydration and antioxidant protection)
- Proteins: trace amounts
- Residual endotoxins: < 0.5 EU/ml
- Molecular weight of HA: approximately 3 million Daltons
- Phosphate–citrate buffer solution (physiological pH and osmolality)
Formulation
- Monophasic, cross-linked hyaluronic acid gel skin booster stabilised with glycerol
- Hyaluronic acid concentration: 18 mg/ml
- Glycerol concentration: 20 mg/ml
- Non-animal, bacterial-origin HA purified to very low protein and endotoxin levels
- Sterile, apyrogenic, transparent viscoelastic gel for injection into the superficial dermis
- Medical device for professional use only (soft tissue augmentation / skin booster)
Packaging
- Single pre-filled glass syringe containing 1 ml of PLURYAL BOOSTER gel
- Packaged with 2 x 30G 1/2" Terumo ultra-thin wall needles
- Sterile blister packaging within an outer carton labelled with batch number and expiry date
- Intended for single-patient, single-use only
Usage
- PLURYAL BOOSTER is a medical device for medical use and must only be administered by appropriately trained and qualified practitioners who have received specific training in soft-tissue augmentation and skin booster injection techniques.
- Before treatment, take a full medical history, assess indications and rule out contraindications. Obtain informed consent and document the planned treatment areas (face, neck, décolletage, back of hands).
- Cleanse and disinfect the treatment area thoroughly. If appropriate, apply a topical anaesthetic according to clinic protocol and allow sufficient time for effect.
- Open the blister pack, attach one of the supplied 30G 1/2" needles to the pre-filled 1 ml syringe under aseptic conditions, and expel any air bubbles prior to injection.
- Inject PLURYAL BOOSTER into the superficial dermis using appropriate techniques (e.g. micro-papules, nappage, serial puncture, or very superficial linear threading), keeping injections shallow and evenly distributed to avoid over-correction or lumpiness.
- Recommended treatment areas include the face, neck, décolletage and back of hands; adapt injection patterns and volumes to the patient’s specific skin quality and degree of aging.
- Typical treatment frequency is every 4–6 months. Some protocols use an initial series of sessions (e.g. 1–3 treatments spaced several weeks apart) followed by maintenance every 4–6 months, according to clinical judgement and patient needs.
- Do not inject into blood vessels, muscles or very superficially into the epidermis. Avoid high-pressure injection and always inject slowly while observing tissue response.
- After injection, gently massage the treated areas if needed to distribute the gel evenly and smooth out any visible irregularities, avoiding excessive pressure.
- Advise patients to avoid makeup, alcohol, saunas, extreme temperatures and strenuous exercise for at least 24 hours, and to protect treated areas from intense sun exposure for several days.
- Instruct patients to report any sustained pain, significant swelling, discoloration, nodules, or other unexpected reactions promptly for assessment and management.
- Refer to the official PLURYAL BOOSTER Instructions for Use (IFU) and professional brochures for complete and up-to-date guidance on indications, techniques, precautions and management of adverse events.
Contraindications
- Hypersensitivity or allergy to hyaluronic acid, glycerol or any component of the formulation
- History of severe allergic reactions or anaphylaxis to injectable HA products
- Active skin infection, inflammation or dermatologic disease at or near the intended injection sites (e.g. herpes simplex, bacterial or fungal infection, dermatitis)
- Autoimmune diseases or immunodeficiency conditions where injectable HA may be contraindicated, unless cleared by a specialist
- Known tendency to keloid formation or hypertrophic scarring in the treatment area
- Bleeding disorders or current use of anticoagulant/antiplatelet medication that significantly increases bleeding risk, unless assessed and approved by a prescribing clinician
- Pregnancy and breastfeeding (commonly listed as contraindications or strong precautions for aesthetic injectables)
- Previous permanent fillers or implants in the same area where interaction or irregularity might occur, unless evaluated by an experienced injector
- Any additional contraindications and warnings stated in the official PLURYAL BOOSTER Instructions for Use
Adverse Effects
- Typical, usually transient injection-site reactions: redness, swelling, tenderness, pain, warmth, itching, bruising or slight bleeding
- Transient papules or small lumps at injection points, usually resolving as the product integrates and oedema subsides
- Temporary asymmetry, irregular texture or overcorrection, which generally settle as swelling decreases or may require corrective treatment
- Rare hypersensitivity or inflammatory reactions, including prolonged swelling or induration
- Risk of infection at injection sites if aseptic technique is not strictly followed
- Very rare but serious vascular complications (e.g. intravascular injection causing ischaemia, necrosis or visual disturbance) as with all injectable fillers/boosters; require immediate recognition and specialist management
- Any other adverse events described in the official PLURYAL BOOSTER IFU, which practitioners should review before use
Storage Conditions
- Store in a clean, dry place at controlled room temperature, typically between 2°C and 25°C, as indicated on the packaging.
- Protect from direct sunlight and sources of heat or cold; do not freeze.
- Keep syringes in their original blister and outer carton until use to maintain sterility and traceability.
- Do not use after the expiry date printed on the pack or if the packaging, syringe or sterility seals are damaged.
- Discard any unused product after opening a syringe; PLURYAL BOOSTER is intended for single-patient, single-use only.
Duration
Results typically last about 4\u20136 months, after which treatment is usually repeated every 4\u20136 months to maintain skin hydration, density and glow. Duration can vary depending on skin condition, treatment area, injection technique and individual lifestyle factors.
Onset
Improvement in hydration, radiance and skin smoothness is usually visible shortly after treatment, with optimal glow and texture benefits developing over the following days to weeks as the skin retains moisture and antioxidant effects take hold.
