Lanluma X 1 x 40 ml
Lanluma
Injectable aesthetic fillerPoly-L-lactic acid (PLLA) collagen-stimulating filler for face and body
Certifications
- CE 1023 medical device marking (European conformity for medical devices).
- Compliance with applicable ISO standards for quality and safety of medical devices, as referenced by the manufacturer.
- Marketed in accordance with EU/UK medical device regulations via Sinclair and associated distributors.
- CE 1023 medical device marking (European conformity for medical devices).
- Compliance with applicable ISO standards for quality and safety of medical devices, as referenced by the manufacturer.
- Marketed in accordance with EU/UK medical device regulations via Sinclair and associated distributors.
Poly-L-lactic acid (PLLA) collagen-stimulating filler for face and body
Description
Lanluma X is an injectable poly-L-lactic acid (PLLA) collagen-stimulating filler for face and body contouring. Supplied as a lyophilised powder to be reconstituted to 40 ml, it is designed primarily for volumising and reshaping larger body areas such as the buttocks, hips and thighs, and can also be used for correcting skin depressions and contour defects. By stimulating the body’s own collagen production, Lanluma X gradually improves volume, skin texture and firmness with long-lasting, natural-looking results.
Bnefits
- Poly-L-lactic acid (PLLA) collagen stimulator that activates the body’s own collagen production rather than acting as a simple space-occupying gel.
- Suitable for both body and selected facial indications, including contouring and volumising of larger areas such as buttocks and hips.
- Gradual, natural-looking improvement in volume and skin quality over several weeks to months, avoiding sudden, dramatic changes.
- Long-lasting results, typically up to 2 years or more after a completed treatment course, depending on patient factors and treatment area.
- Large 40 ml reconstitution volume tailored for body contouring procedures, allowing treatment of extensive areas.
- Can improve the appearance of cellulite and skin laxity by enhancing dermal thickness and skin quality.
- Minimal downtime when injected by trained medical professionals, with patients usually returning to normal activities shortly after treatment.
- Backed by CE certification (CE 1023) and use of PLLA, a material with over 30 years of medical use in various implantable devices.
Indications
- Increasing the volume of depressed areas and correction of skin depressions (e.g. contour defects).
- Body contouring and volumisation, especially buttock augmentation and reshaping and improvement of hip dips.
- Improvement of skin flaccidity and laxity on body areas such as buttocks, thighs, abdomen, arms and other appropriate regions.
- Adjunctive treatment to improve the appearance of cellulite by enhancing skin thickness and texture.
- Selected facial indications for volume restoration and treatment of medium to deep lines and folds (in accordance with local labelling and clinician judgement).
Composition
- Poly-L-lactic acid (PLLA) – approx. 40.4% w/w (biodegradable collagen-stimulating polymer).
- Carboxymethyl cellulose (CMC) – approx. 25.4% w/w (suspending and stabilising agent).
- Mannitol – approx. 34.2% w/w (cryoprotectant and excipient to aid reconstitution and stability).
- Supplied as a sterile, apyrogenic, lyophilised powder for suspension in sterile water for injection.
Formulation
- Lyophilised poly-L-lactic acid implant for suspension for injection.
- Single vial intended to be reconstituted with sterile water for injection to a total volume of approximately 40 ml before use.
- Injectable collagen-stimulating implant classified as a CE-marked medical device in the EU.
Packaging
- Carton containing 1 sterile glass vial of Lanluma X PLLA powder (dose for 40 ml reconstitution).
- Each vial sealed with a rubber stopper and tear-off cap, supplied in secondary packaging with Instructions for Use (IFU) in applicable markets.
Usage
- For use only by appropriately trained and qualified healthcare professionals experienced in PLLA injection techniques and anatomy of the planned treatment areas.
- Reconstitute the lyophilised powder in the vial with the recommended volume of sterile water for injection (typically 40–60 ml per vial according to the latest protocol/IFU).
- After adding sterile water, shake/agitate the vial for several minutes to disperse the particles, then allow it to stand (often 1–12 hours, up to 72 hours depending on protocol) to ensure complete hydration before injection. Shake again immediately prior to use to obtain a uniform suspension.
- Draw the reconstituted suspension into sterile syringes using an appropriate gauge needle; injection is generally performed with a blunt cannula (e.g. 18–21G) or appropriate needle according to the IFU and treatment plan.
- Inject into deep dermal, sub-dermal or deep subcutaneous tissue (or supraperiosteal for some facial areas) using fanning or retrograde threading techniques to ensure even distribution, strictly avoiding intravascular injection.
- Typical treatment plans involve 1–3 sessions for facial indications and 2–4 sessions for body contouring, spaced approximately 4–6 weeks apart, tailored to indication and patient factors.
- After each treatment, the treated area is usually massaged to help distribute the product evenly; patients are often advised to massage the area at home (e.g. 10 minutes, 2–3 times daily for several days) as directed by their clinician.
- Do not inject into areas with active skin disease, infection, inflammation, or in the presence of permanent fillers or implants; follow all contraindications and precautions from the official IFU.
- Use any reconstituted product within the timeframe specified in the IFU (commonly within 72 hours of reconstitution) and discard any unused suspension thereafter in accordance with local regulations.
Contraindications
- Hypersensitivity or allergy to poly-L-lactic acid (PLLA) or any of the excipients (carboxymethyl cellulose, mannitol).
- Presence of active skin infections, inflammation or dermatological conditions (e.g. active herpes, dermatitis) at or near the intended injection sites.
- Patients with a history of severe allergic reactions, anaphylaxis or known hypersensitivity to injectable implants.
- Known autoimmune or connective tissue diseases where injectable implants may be contraindicated, unless the treating physician determines otherwise with appropriate caution.
- Pregnancy and breastfeeding (use is generally not recommended in these populations due to lack of safety data).
- Patients under 18 years of age.
- Injection into areas with permanent dermal fillers or implants or into scar tissue where product behaviour may be unpredictable.
- Coagulation disorders or current use of anticoagulant or antiplatelet therapy that significantly increases bleeding risk at injection sites, unless the risk–benefit has been carefully evaluated.
- Any other contraindications, warnings or precautions listed in the official Lanluma Instructions for Use (IFU) should be strictly followed.
Adverse Effects
- Common, usually transient injection-site reactions such as redness (erythema), swelling, tenderness, warmth, pain, bruising or pruritus.
- Small nodules, papules, lumps or areas of induration at or near injection sites, which are typically mild and may resolve spontaneously or with conservative management.
- Haematoma, ecchymosis or local bleeding at injection sites.
- Infection at the injection site if aseptic technique is not adequately maintained.
- As with other injectable fillers, rare but serious complications such as vascular occlusion, tissue necrosis or visual compromise/vision loss can occur if product is inadvertently injected into a blood vessel.
- Hypersensitivity reactions including swelling or inflammatory responses; in very rare cases, more significant immune-mediated reactions may be possible.
- Any additional adverse events listed in the official IFU should be considered; patients should be counselled to report unexpected or persistent symptoms promptly.
Storage Conditions
- Store unopened vials at controlled room temperature, typically between 2°C and 25°C, in a cool, dry place away from direct sunlight and heat sources, in accordance with the device labelling.
- Keep vials in their original packaging until use to protect from light and contamination.
- Do not freeze the product.
- After reconstitution, use the suspension within the period specified in the Instructions for Use (commonly within 72 hours), keeping it under recommended conditions and discarding any unused portion thereafter.
- Always refer to the latest official IFU for the most precise and legally binding storage instructions for the specific batch and market.
Duration
Results typically require a series of 1\u20133 sessions for facial indications and 2\u20134 sessions for body contouring, spaced about 4\u20136 weeks apart. Collagen stimulation and visible improvement generally develop over 2\u20136 months, with clinical results often maintained for up to approximately 2 years after the completed treatment course, depending on the treatment area, patient age, lifestyle and metabolism.
Onset
Volume and skin-quality changes develop gradually, with early improvements often starting to become visible around 6\u20138 weeks after treatment and continuing to improve over 2\u20133 months and beyond as new collagen is formed.
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