Class III injectable medical device in the European Union/UK classification framework for high Risk medical devices.
CE Marked device for soft Tissue augmentation and collagen induction in approved indications.
Korean MFDS (KFDA) approval as a hybrid PDLLA + HA soft Tissue injectable implant.
Multiple sources describe FDA and MHRA approval/registration for the PDLLA technology and product family in relevant markets.
Class III injectable medical device in the European Union/UK classification framework for high Risk medical devices.
CE Marked device for soft Tissue augmentation and collagen induction in approved indications.
Korean MFDS (KFDA) approval as a hybrid PDLLA + HA soft Tissue injectable implant.
Multiple sources describe FDA and MHRA approval/registration for the PDLLA technology and product family in relevant markets.
Manufactured under quality systems consistent with ISO standards for medical devices and sterile injectables (as stated in manufacturer and distributor technical documentation).
Description
JuveLook Volume 200mg is a premium PLA/HA hybrid soft-tissue injectable implant designed for long-lasting volume restoration and collagen induction. Each vial contains 200 mg of lyophilised Poly-D,L-lactic acid (PDLLA) and non-crosslinked hyaluronic acid (HA). The HA component provides an immediate hydrating and volumising effect, while PDLLA microparticles stimulate neocollagenesis over many months. JuveLook Volume is intended for subcutaneous and lower-dermal implantation to restore lost volume, contour and lift facial structures, and improve overall skin firmness and texture. It is particularly suited to deeper volume loss and contouring of areas such as cheeks, jawline, nasolabial folds, temples and other medium-to-deep defects.
Bnefits
Hybrid technology combining immediate HA volumisation with long-term PDLLA-driven collagen stimulation
Designed for volume restoration and contouring in medium-to-deep volume loss
Gradual, natural-looking results without an overfilled appearance
Improves skin thickness, elasticity and overall texture over time
Long duration of effect, typically 18–24 months or longer after the last treatment
Biocompatible and biodegradable materials that are gradually resorbed by the body
Can treat multiple anatomical areas including midface, jawline, nasolabial folds, under-eye hollows, neck and décolletage
Supplied as lyophilised powder for controlled reconstitution and tailored treatment protocols
Formulated for smooth injection and reduced risk of needle/cannula clogging
Used only by trained medical professionals for controlled and precise placement
Indications
Restoration of facial volume in areas such as cheeks, midface and temples
Contour and lift of the jawline and lower face
Correction of medium-to-deep wrinkles and folds (e.g. nasolabial folds, marionette lines)
Treatment of under-eye hollows, tear troughs and dark-circle related volume loss (in suitably selected patients by experienced injectors)
Skin laxity and loss of firmness in the face, neck and décolletage
Enlarged pores and uneven skin texture when used in appropriate dilution protocols
Manufactured under quality systems consistent with ISO standards for medical devices and sterile injectables (as stated in manufacturer and distributor technical documentation).
Hybrid PDLLA + hyaluronic acid volume filler
Volume replacement and rejuvenation of the dorsal hands (in approved markets and protocols)
Supportive treatment for certain atrophic acne scars and other atrophic scars
General biostimulation and collagen induction in ageing or photo-damaged skin where volume and firmness are reduced
Composition
Poly-D,L-lactic acid (PDLLA) 170 mg per vial (microparticles, average particle size approximately 50–60 µm in Volume formulation)
Non-crosslinked hyaluronic acid 30 mg per vial (approximate molecular weight around 3000 kDa as described by technical data)
Lyophilised powder requiring reconstitution with sterile normal saline prior to injection
No lidocaine in the vial (local anaesthetic can be added separately according to local protocol, if permitted)
Sterile excipients and manufacturing process consistent with a Class III injectable medical device
Formulation
Lyophilised PDLLA + non-crosslinked HA hybrid soft-tissue injectable implant
200 mg total solids per vial (170 mg PDLLA + 30 mg HA)
PDLLA microparticles with optimised spherical/porous morphology for controlled collagen induction and gradual resorption
Designed for subcutaneous and lower-dermal injection for volume augmentation and contouring
Supplied as a single-use, sterile, disposable medical device
Packaging
Box containing 1 x 200 mg vial of JuveLook Volume (hybrid PDLLA + HA lyophilised powder)
Vial intended to be reconstituted with sterile saline immediately prior to use
In some commercial sets, supplied together with sterile saline (e.g. 20 ml) and recommended cannula/needle (typically 23G–27G) depending on supplier
Tamper-evident packaging with security features such as QR/scratch-off authenticity code in many markets
Usage
For professional use only by trained and appropriately qualified medical practitioners experienced in injectable aesthetic procedures.
Reconstitute the lyophilised contents of one 200 mg vial with sterile normal saline according to the instructions for use (IFU). Many manufacturer and distributor protocols describe initial reconstitution with approximately 3 ml sterile saline; some clinical experts may use higher dilutions based on specific treatment goals and local guidance.
Allow the reconstituted suspension to fully hydrate for the period specified in the IFU before injection; gentle swirling (not vigorous shaking) is generally recommended to ensure a homogeneous suspension without foam.
Inject into the subcutaneous or lower-dermal layer using an appropriate sterile cannula or needle (commonly 23G–27G cannula or 25–31G needle, depending on area and technique).
Typical anatomic targets for JuveLook Volume include midface/cheeks, jawline, nasolabial folds, marionette lines, temples, and in some advanced protocols under-eye hollows, neck and décolletage; injection depth and technique must be adapted to each area.
Dosage and injection pattern (linear threading, fanning, bolus, or micro-droplet) should be individualised based on degree of volume loss, skin quality and patient goals, following official training and product guidelines.
Common treatment protocols recommend 1 vial per session, repeated for 2–3 sessions separated by approximately 4–8 weeks, with optional maintenance or booster treatment after 18–24 months depending on the persistence of clinical effect.
After treatment, patients are typically advised to avoid excessive UV exposure, saunas, intense exercise and manipulation of the treated area for a defined period (often 24–72 hours) and to follow any specific aftercare instructions (e.g. gentle massage if recommended in the IFU).
Product must not be injected intravascularly or into highly superficial dermal planes; meticulous aspiration, slow injection and awareness of vascular anatomy are essential to minimise risk of vascular compromise.
Always consult the official instructions for use and local clinical training materials for detailed reconstitution volumes, injection techniques, contraindications and precautions.
Contraindications
Hypersensitivity or known allergy to any component of the product (PDLLA, hyaluronic acid or formulation excipients).
Active infection, inflammation, dermatitis or eczema in or near the intended injection sites.
History of severe allergic reactions or anaphylaxis to injectable implants or fillers.
Known bleeding disorders, current significant anticoagulant therapy (unless carefully assessed and managed according to local guidelines).
Autoimmune diseases or immunosuppression where implantable biostimulators are contraindicated according to local guidance.
Pregnancy or breastfeeding (use is generally not recommended due to lack of safety data).
History of keloid or hypertrophic scarring in the areas to be treated, where biostimulatory fillers may pose additional risk.
Recent laser resurfacing, chemical peels, or other invasive procedures in the intended treatment area, until full healing has occurred.
Any other condition listed as a contraindication in the official JuveLook Volume instructions for use or by local regulatory guidance.
Adverse Effects
Typical injection-related reactions such as transient redness, swelling, tenderness, itching, pain, bruising or mild oedema at the injection site, usually resolving within a few days.
Temporary firmness or palpable nodules in the treated areas as collagen forms around PDLLA particles; these often soften with time but may require massage or medical management if persistent.
As with other injectable biostimulators, rare delayed inflammatory or granulomatous reactions can occur and may require targeted medical treatment.
Asymmetry or irregularity of contour if product placement or integration is uneven.
Very rare but serious events such as vascular occlusion or skin necrosis if product is inadvertently injected intravascularly; immediate recognition and emergency management are critical.
Risk of visual disturbance or blindness in the event of embolisation into periocular or retinal vessels, as with other injectable fillers used near high-risk vascular territories.
Infections at the injection site or deeper tissues if aseptic technique is not strictly observed.
Any unexpected or persistent adverse event should prompt clinical reassessment and, where appropriate, reporting to local regulatory pharmacovigilance or device vigilance systems.
Storage Conditions
Store in a cool, dry place away from direct sunlight.
Recommended storage temperature typically between 2 °C and 25–28 °C, as per distributor technical data and IFU.
Do not freeze the product.
Keep vials in their original packaging until use to protect from light and physical damage.
Use immediately after reconstitution and do not resterilise or reuse any remaining suspension or packaging components.
Keep out of reach of unauthorised persons and store in accordance with local regulations for medical devices.
Duration
Clinical sources and manufacturer-backed data report long-lasting effects; collagen stimulation and clinical improvements typically persist for approximately 18\u201324 months or longer after completion of a 2\u20133 session protocol, with many patients maintaining visible benefit for over 2 years.
Onset
An immediate but subtle hydrating and filling effect is usually visible after injection due to the HA component. Collagen stimulation from PDLLA begins within roughly 2 weeks, with progressive improvement in volume, firmness, texture and elasticity over 1\u20132 months following treatment. Full results are generally observed several weeks after the final session.
