Harmoni PLLA Skin Booster (1 x 214mg/vial)
HARMONI
Aesthetic injectablesPLLA collagen biostimulator / skin booster
Certifications
- Categorised by the manufacturer as a cosmetic product with CPNP (European Cosmetic Products Notification Portal) registration/certification
- Developed and manufactured by GMC Med, a company specialised in aesthetic products and dermatological medical devices
- Ingredients (PLLA and hyaluronic acid) described as using components that are recognised and approved in other medical and cosmetic applications (e.g. FDA and Korean MFDS approvals for these ingredient types), though the complete product may not itself be a licensed medicinal product in all territories
- Categorised by the manufacturer as a cosmetic product with CPNP (European Cosmetic Products Notification Portal) registration/certification
- Developed and manufactured by GMC Med, a company specialised in aesthetic products and dermatological medical devices
- Ingredients (PLLA and hyaluronic acid) described as using components that are recognised and approved in other medical and cosmetic applications (e.g. FDA and Korean MFDS approvals for these ingredient types), though the complete product may not itself be a licensed medicinal product in all territories
PLLA collagen biostimulator / skin booster
Description
Harmoni PLLA Skin Booster is an injectable poly-L-lactic acid (PLLA) based collagen biostimulator combined with high and low molecular weight hyaluronic acid. Supplied as a 214mg vial (PLLA 150mg, H-HA 32mg, L-HA 32mg), it is injected into the subcutaneous layer by trained professionals to stimulate endogenous collagen production, increase skin elasticity and volume, and improve the appearance of wrinkles and hollow or sunken facial areas. The product provides gradual, natural-looking volumisation with effects that begin to appear from weeks 4–5 after treatment and can last for up to approximately 25 months when used as directed.
Bnefits
- Stimulates the skin’s own collagen production for gradual, natural volumisation
- Improves skin elasticity and firmness over time
- Reduces the appearance of wrinkles and fine lines
- Helps to correct hollow or sunken areas such as cheeks, temples and jawline
- Provides long-lasting results, with effects reported for up to around 25 months
- Can be applied to multiple facial areas that require volume restoration
- Combines PLLA with hyaluronic acid to support hydration and skin texture
- Procedure designed for quick recovery when performed correctly (minimal swelling and bruising in most cases)
Indications
- Patients seeking to slow visible signs of skin ageing and appear more refreshed and vibrant
- Correction of nasolabial folds and other facial wrinkles
- Volumisation of hollow or sunken areas such as cheeks, temples and jawline
- General improvement of skin elasticity, firmness and texture
- Patients desiring natural yet noticeable, progressive results
- Patients seeking a biostimulatory treatment with effects lasting beyond typical HA fillers
Composition
- Poly-L-lactic acid (PLLA) 150 mg
- Hyaluronic acid – high molecular weight (H-HA) 32 mg
- Hyaluronic acid – low molecular weight (L-HA) 32 mg
- Other excipients as listed in the manufacturer’s instructions for use
Formulation
- Lyophilised PLLA-based collagen biostimulator with combined high and low molecular weight hyaluronic acid
- Supplied as a sterile, single-use vial intended to be reconstituted with sterile diluent prior to injection
- For subcutaneous / deep-tissue injection by appropriately trained medical professionals only
Packaging
- Box containing 1 x 214 mg vial
- Professional-use packaging intended for clinic / medical aesthetic settings
Usage
- For use only by suitably trained and qualified healthcare professionals experienced with injectable collagen biostimulators.
- Reconstitute the lyophilised contents of the vial with the volume and type of sterile diluent specified in the official manufacturer instructions for use (IFU).
- Allow adequate time after reconstitution as directed in the IFU to ensure homogeneous dispersion of PLLA particles.
- Inject into the appropriate tissue plane (typically subcutaneous or deep dermal layer) using an aseptic technique and suitable needle or cannula, avoiding intravascular injection.
- Distribute product evenly in small aliquots according to the treatment plan and anatomical considerations.
- Gently massage the treated area if recommended in the IFU to help even distribution of the product.
- Advise patients on post-procedure care in line with best practice and manufacturer guidance (for example, avoiding extreme heat/cold, heavy exercise or manipulation of treated areas for a specified period).
- Dispose of any unused reconstituted product and used materials according to local regulations and clinical waste protocols.
Contraindications
- Known hypersensitivity or allergy to poly-L-lactic acid, hyaluronic acid or any other component of the formulation
- Active infection, inflammation or skin disease at or near the intended injection sites
- History of severe allergic reactions or anaphylaxis to injectable implants or similar products
- Uncontrolled autoimmune or immunodeficiency disorders where injectable implants may pose additional risk
- Pregnancy or breastfeeding (use generally not recommended due to lack of safety data)
- Bleeding disorders or current use of significant anticoagulant / antiplatelet therapy where injection risk cannot be adequately managed
- History of keloid formation or hypertrophic scarring in the planned treatment area
- Any other condition that, in the clinician’s judgment, makes treatment inappropriate or unsafe
Adverse Effects
- Transient injection site reactions such as redness, swelling, tenderness, pain, warmth or bruising
- Itching or discomfort at the injection site
- Formation of palpable nodules, papules or indurations in the treated area
- Asymmetry or uneven correction if product distribution is not uniform
- Rare risk of infection at injection sites
- Rare risk of vascular compromise or embolic events if inadvertently injected intravascularly
- Other adverse effects associated with injectable collagen biostimulators and dermal implants as described in the official IFU
Storage Conditions
- Store unopened vials in their original packaging in a clean, dry place, protected from direct sunlight.
- Do not freeze. Avoid excessive heat; store within the temperature range recommended in the manufacturer’s instructions (typically controlled room temperature).
- Keep out of the reach and sight of children.
- Use only within the stated shelf-life and follow all storage and handling instructions provided by the manufacturer.
Duration
Treatment protocols are individualised and typically involve one or more sessions spaced several weeks apart, with clinical effects reported to last for up to approximately 25 months after a completed treatment course.
Onset
Subtle improvement may be visible shortly after injection from immediate volume and hydration, with collagen-stimulated volume and elasticity changes generally developing from around weeks 4\u20135 and progressively increasing over subsequent months.
