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Plejuv PLLA (Poly L Lactic Acid) Injectable Powder (1 x 365mg)

Plejuv PLLA (Poly L Lactic Acid) Injectable Powder (1 x 365mg)

Plejuv

Dermal filler
  • CE Marked sterile absorbable dermal filler, indicated on packaging and marketing materials as CE approved (reported with CE mark 1434 on promotional materials).
  • PLLA identified as a biocompatible, biodegradable medical material with long Standing regulatory acceptance and use in medical devices, and recognised by major regulators (e.g. MFDS in Korea) as a collagen stimulator component.
  • Manufactured as a medical device under quality systems consistent with ISO and CE certification claims referenced in distributor and wholesaler documentation.
Collagen-stimulating PLLA injectable / skin booster

Description

Plejuv PLLA is an injectable poly-L-lactic acid (PLLA) dermal filler supplied as a sterile lyophilised powder in a 365 mg vial. It acts as a collagen-stimulating biostimulatory filler designed for the gradual correction of volume loss and deep wrinkles by inducing neocollagenesis in the treated tissues. When reconstituted and injected by trained medical professionals into the dermis or subcutaneous tissue, Plejuv restores facial volume, improves skin elasticity and firmness, and softens facial contour deformities, with progressive results that can last for up to about two years.

Bnefits

  • Collagen-stimulating dermal filler based on poly-L-lactic acid (PLLA) that promotes gradual, natural-looking volume restoration.
  • Targets age-related collagen loss to firm the skin and improve elasticity, reducing the appearance of sagging and deep wrinkles.
  • Provides both progressive and immediate improvement in facial volume and contour as collagen is formed over time.
  • Indicated for volume loss, deep facial wrinkles and folds, facial lipoatrophy and contour irregularities, as well as hand and neck enhancement and scar refinement.
  • CE-marked medical device produced by PRP Life Science Co. LTD, with PLLA confirmed as a safe medical material and collagen stimulator.
  • Therapeutic effects may persist for around two years after a course of treatments, depending on the patient and treatment protocol.
  • Supplied as a powder for reconstitution, enabling controlled dilution and tailoring of treatment to individual patient needs.

Indications

  • Treatment of deep facial wrinkles and folds.
  • Replacement of volume loss and correction of facial lipoatrophy.
  • Improvement of facial contour deformities.
  • Hand rejuvenation and neck enhancement.
  • Refinement of certain atrophic scars where collagen stimulation is desired.
  • Use by appropriately trained medical professionals for biostimulatory volumising of the face, neck and décolletage.

Composition

  • Poly-L-lactic acid (PLLA) 150 mg per vial (biodegradable synthetic polymer and primary collagen-stimulating component).
  • Sodium carboxymethylcellulose 90 mg per vial (suspending agent).
  • Mannitol 125 mg per vial (cryoprotectant and excipient).
  • Total dry powder content: 365 mg per vial.

Formulation

  • Sterile lyophilised powder for suspension for injection.
  • One vial contains a total of 365 mg dry powder (PLLA, sodium carboxymethylcellulose and mannitol).
  • Poly-L-lactic acid-based biostimulatory dermal filler intended for reconstitution with sterile diluent prior to injection.
  • Single-use vial; the reconstituted suspension is intended for immediate use by a qualified medical professional.

Packaging

  • Each box contains 1 x 365 mg vial (1 x 5.0 ml nominal volume after reconstitution).
  • Outer carton printed with product name, active ingredient (Poly L-Lactic Acid), CE mark and basic product information.
  • Supplied as a sterile, single-use medical device for professional use only.

Usage

  • For use only by suitably trained and qualified healthcare professionals experienced in injectable biostimulatory fillers.
  • Reconstitute the product according to the supplier’s guidance: for example, 1 vial (5 ml) of Plejuv may be mixed with 7 ml of sterile saline and 2 ml of lidocaine to obtain approximately 9 ml of diluted suspension (3 ml in each of three syringes).
  • Allow sufficient time after reconstitution (according to local protocol and manufacturer guidance) for the powder to fully hydrate, with gentle agitation as required to obtain a uniform suspension.
  • Inject the reconstituted product into the appropriate dermal or subcutaneous plane using aseptic technique, following established PLLA injection guidelines (e.g. small aliquots in a fan or threading technique), avoiding intravascular injection.
  • Treat indicated areas such as deep wrinkles, folds or volume-deficient regions of the face, neck, hands or selected scars, adjusting volume and placement to the individual patient.
  • Typical treatment regimens consist of 2–3 sessions spaced several weeks apart; the exact protocol should be tailored by the treating clinician based on patient needs, indications and response.
  • After injection, gently massage the treated areas according to standard PLLA practice to help distribute the product evenly, and advise the patient regarding any recommended post-treatment massage routine and care (e.g. avoiding extreme heat or strenuous exercise for a short period, as per clinic protocol).
  • Dispose of any unused reconstituted product and sharps in accordance with local clinical waste regulations; do not store or reuse reconstituted suspensions.

Contraindications

  • Use in patients with known hypersensitivity to poly-L-lactic acid, sodium carboxymethylcellulose, mannitol or any component of the product.
  • Injection into areas with active skin disease or infection (e.g. dermatitis, psoriasis, active acne or local infection) at or near the treatment site.
  • Use in patients with uncontrolled systemic disease, severe autoimmune disorders, or those prone to hypertrophic scarring or keloid formation, unless the risk–benefit has been carefully evaluated.
  • Injection into blood vessels or in areas where there is a high risk of intravascular injection (e.g. glabellar region) is contraindicated.
  • Use in pregnant or breastfeeding women, or in patients under 18 years of age, is generally not recommended due to lack of safety data.
  • Not intended for use by non-medical personnel or for self-administration.

Adverse Effects

  • Common injection-related reactions such as transient redness, swelling, tenderness, bruising, or mild pain at the injection site.
  • Temporary lumps, nodules or unevenness in the treated area, which may improve with massage or over time as the product integrates and collagen forms.
  • Less commonly, inflammatory nodules, induration or granuloma formation may occur and can require medical management.
  • Rare but serious complications associated with injectable fillers, including vascular occlusion, tissue ischemia or necrosis, visual disturbance or blindness, may occur if product is inadvertently injected intravascularly.
  • Hypersensitivity or allergic reactions are possible in susceptible individuals.
  • As with any injectable treatment, there is a risk of infection if aseptic technique is not strictly followed.

Storage Conditions

  • Store in a cool, dry place away from direct sunlight, in accordance with the manufacturer’s recommended temperature range (typically controlled room temperature).
  • Do not freeze and protect from excessive heat and humidity.
  • Keep the vial in its original outer carton until use to protect from light and contamination.
  • Do not use after the expiry date printed on the packaging, and do not use if the vial or packaging is damaged.

Duration

Results typically appear progressively over several weeks as new collagen forms, with clinical sources describing effects that may last for approximately 18\u201324 months after a course of 2\u20133 treatment sessions, depending on individual patient factors and technique.

Onset

Some immediate improvement may be visible from injection-related volume, but the primary effect develops gradually over weeks to months as PLLA stimulates neocollagenesis; noticeable improvement is generally observed after several weeks and continues to build with subsequent sessions.

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