Class III injectable medical device with CE marking (CE 2764) for intradermal and subcutaneous implantation.
Biocompatible and biodegradable PDLLA + HA Based collagen inductor, designed and manufactured under medical device quality standards such as ISO 13485 (as declared by manufacturer/distributors).
Marketed in Europe through Laboratoires FILLMED and associated distributors for professional use in aesthetic medicine.
Class III injectable medical device with CE marking (CE 2764) for intradermal and subcutaneous implantation.
Biocompatible and biodegradable PDLLA + HA Based collagen inductor, designed and manufactured under medical device quality standards such as ISO 13485 (as declared by manufacturer/distributors).
Marketed in Europe through Laboratoires FILLMED and associated distributors for professional use in aesthetic medicine.
Not included in the list referred to in Article L.165 1 of the French Social Security Code (not reimbursed by French Social Security).
Description
JUVELOOK 50mg/vial is a Class III CE-marked injectable medical device (CE 2764) that combines Poly-D,L-lactic acid (PDLLA) microspheres with non-crosslinked hyaluronic acid (HA) in a lyophilised powder. Intended for intradermal and subcutaneous implantation, it is designed to fill skin depressions, restore and increase soft tissue volume and improve overall skin quality. JUVELOOK is optimised for very delicate and challenging areas, especially the eye area (tear trough and lower eyelid) and for skin mesotherapy. The hybrid PDLLA + HA formulation provides immediate hydration and subtle filling from HA, while PDLLA particles (20–40 μm) stimulate collagen to refine and tighten skin texture, with skin-quality rejuvenation reported for up to 16 months when used according to protocol by trained medical professionals.
Bnefits
Hybrid PDLLA + HA formulation offers both immediate hydrating and long-term collagen-stimulating effects.
Designed for very delicate and challenging areas, particularly the tear trough and lower eyelid region.
Refines and tightens skin texture, improving skin quality for up to approximately 16 months.
Improves fine lines and skin depressions and restores soft tissue volume in superficial and mid-depth layers.
Indicated for treatment of tear troughs, skin pore tightening, skin texture improvement and atrophic scar treatment.
Can be used for skin brightening and stretch mark treatment in suitable candidates.
High tissue biocompatibility and strong collagen stimulation profile due to PDLLA microspheres.
Small PDLLA particle size (20–40 μm) designed for smooth intradermal injection and even distribution in the deep dermis.
Part of a multilayer biostimulatory system (with LENISNA for subcutaneous volume) allowing personalised treatment of different ageing grades.
Indications
Device intended for intradermal and subcutaneous implantation to fill skin depressions.
Restoration and increase of soft tissue volume in areas of atrophy or volume loss.
Reconstructive purposes in the treatment of morphological asymmetries.
Skin quality rejuvenation with improvement of texture and firmness for up to about 16 months.
Refinement and tightening of skin texture ("Refine & Tighten" indication).
Treatment of tear trough and lower eyelid area in patients with slight ageing and damaged skin quality.
Tear trough correction and improvement of infraorbital hollowing.
Skin pore tightening and overall skin texture improvement.
Atrophic scar treatments (e.g. acne scars) in appropriate candidates.
Skin brightening and stretch mark treatment as part of a global rejuvenation protocol.
Composition
Total lyophilised powder content per vial: 50 mg.
Poly-D,L-lactic acid (PDLLA): 42.5 mg per vial.
Non-crosslinked hyaluronic acid (HA): 7.5 mg per vial.
PDLLA particle size: 20–40 μm (2/4 size range) designed for injection into the deep dermis.
Additional excipients: buffering and stabilising agents suitable for lyophilised injectable medical devices (full qualitative list in official IFU).
Formulation
Lyophilised sterile powder in a glass vial containing PDLLA microspheres and non-crosslinked HA.
Hybrid collagen-inducing biostimulator combining PDLLA (for gradual collagen stimulation) and HA (for immediate hydration and subtle filling).
Small PDLLA particles (approximately 20–40 μm) optimized for intradermal implantation in the deep dermis.
Biocompatible and biodegradable polymer matrix with high tissue biocompatibility and strong collagen stimulation.
Class III soft-tissue implantable medical device intended for intradermal and subcutaneous administration.
Requires reconstitution with sterile saline according to manufacturer/FILLMED protocol immediately prior to injection.
Formulated for a multilayer approach in combination with LENISNA (subcutaneous PDLLA + HA) for deeper volume restoration when indicated.
Packaging
Single-use carton containing 1 x 50 mg sterile lyophilised powder vial of JUVELOOK.
Each vial is intended for reconstitution and use in a single patient according to protocol.
Outer carton and vial labelled with product name, concentration (PDLLA 42.5 mg + HA 7.5 mg), batch/lot number and expiry date.
Class III CE medical device labelling (CE 2764) and regulatory information printed on packaging.
Accompanied by product leaflet/Instructions for Use (IFU) with indications, protocol, and safety information.
Marked as strictly for medical use and not included in the list referred to in Article L.165-1 of the French Social Security Code.
Usage
For strict medical use only; JUVELOOK must be administered by appropriately trained healthcare professionals experienced in injectable aesthetic procedures and facial anatomy.
The device is intended for intradermal and subcutaneous implantation, with a primary injection layer in the deep dermis for the "Refine & Tighten" skin quality indication.
Reconstitute the 50 mg lyophilised vial with the volume and solvent recommended in the specific product leaflet (sterile saline), following aseptic technique until a homogeneous suspension is obtained.
Use fine needles or cannulas appropriate for intradermal or superficial subcutaneous injection according to the treatment area and clinical protocol.
Administer in micro-bolus or linear/threading patterns in the deep dermis to refine and tighten skin texture and improve quality, particularly in delicate areas such as the tear trough and lower eyelid.
Indicated protocol for JUVELOOK: 3 sessions spaced 6 weeks apart, using 1 vial per session for most standard full-face/area indications, as recommended in FILLMED protocols.
Suitable for patients presenting slight ageing and damaged skin quality; evaluate each patient for appropriate indication and contraindications before treatment.
Do not inject into areas with active infection, inflammation or skin disease, and avoid intravascular injection by careful technique and anatomical knowledge.
Monitor patients during and after injection for any immediate adverse effects and manage according to standard medical practice and local guidelines.
Refer to the specific JUVELOOK and LENISNA product leaflets for full instructions, including reconstitution guidelines, recommended techniques, and complete safety information.
Contraindications
Hypersensitivity or allergy to any of the components, including Poly-D,L-lactic acid, hyaluronic acid or excipients.
Presence of active skin infection, inflammation or disease at or near the intended injection site (e.g. active acne, herpes, cellulitis, dermatitis).
History of severe allergic reactions or anaphylaxis unless a careful risk–benefit assessment has been made by the treating physician.
Known tendency to form hypertrophic scars or keloids in the planned treatment area.
Pregnancy or breastfeeding, as safety has not been established in these populations.
Use in patients under 18 years of age.
Injection into blood vessels or areas with high vascular risk; intravascular injection must be strictly avoided.
Injection into sites with permanent fillers, foreign bodies or poorly vascularised scar tissue without careful evaluation.
Relative contraindication or caution in patients with autoimmune disease, immunosuppression, uncontrolled systemic illness or significant bleeding disorders.
Concomitant anticoagulant or antiplatelet therapy should be carefully evaluated as it may increase bruising and bleeding risk.
Any other contraindication or precaution mentioned in the official JUVELOOK product leaflet and FILLMED safety documentation.
Adverse Effects
Common, usually transient injection-site reactions such as redness, swelling, pain or tenderness, bruising, induration, itching and warmth, which typically resolve within a few days.
Temporary small nodules or indurations at injection points, usually improving as the product integrates and collagen remodelling progresses.
Asymmetry, over- or under-correction of treated areas, potentially requiring adjustment at subsequent sessions.
Infection at the injection site if aseptic technique is not strictly followed or if injected into contaminated tissue.
Delayed inflammatory nodules or granulomatous reactions, a known but uncommon risk with biostimulatory fillers.
Very rare risk of vascular compromise, ischaemia or tissue necrosis if the product is inadvertently injected intravascularly or causes vascular compression.
Temporary oedema, especially in delicate areas such as the periorbital region, typically resolving within several days.
Post-inflammatory hyperpigmentation or skin discolouration in predisposed individuals.
Allergic or hypersensitivity reactions of varying intensity, which may require medical treatment according to standard practice.
Storage Conditions
Store at controlled room temperature as specified in the official product leaflet (commonly 2–25°C), protected from direct light.
Do not freeze; freezing may damage the lyophilised structure and compromise product performance.
Keep the vial in its original outer packaging until use to protect from light and contamination.
Do not use after the expiry date printed on the packaging.
Single-use medical device; any unused reconstituted product must be discarded and must not be re-sterilised or reused.
Transport and store according to standard requirements for Class III injectable medical devices, avoiding extreme temperature fluctuations.
Duration
Manufacturer and distributor information indicates skin quality rejuvenation and textural improvement for up to approximately 16 months after a completed protocol of 3 sessions spaced 6 weeks apart, with maintenance treatments recommended based on clinical assessment.
Onset
Initial improvement in hydration and skin texture is typically observed within weeks of treatment due to the HA component, while collagen stimulation from PDLLA leads to progressive refinement and tightening of the skin over subsequent months following the 3-session protocol.
