Poly-L-lactic acid (PLLA) biostimulatory powder for reconstitution; Class III medical device for facial and body volume restoration
Certifications
Described in official training material and distributor information as a CE Marked Class III medical device in the European Union.
Manufactured by Oreon Life Science, a Korean medical Aesthetic company that states compliance with GMP and ISO 13485 quality management standards for medical devices.
Oreon Life Science company documentation states that its products, including PLLA fillers, are approved under CE or CPNP (as applicable) and exported to multiple international markets.
Described in official training material and distributor information as a CE Marked Class III medical device in the European Union.
Manufactured by Oreon Life Science, a Korean medical Aesthetic company that states compliance with GMP and ISO 13485 quality management standards for medical devices.
Oreon Life Science company documentation states that its products, including PLLA fillers, are approved under CE or CPNP (as applicable) and exported to multiple international markets.
Intended exclusively for professional use in authorised medical and aesthetic settings, with sale in some EU countries restricted to healthcare professionals, clinics, pharmacies, and authorised distributors.
Description
aesPlla 365mg is an injectable poly-L-lactic acid (PLLA)–based collagen stimulator manufactured by Oreon Life Science in South Korea. Supplied as a sterile, lyophilised powder for suspension, it is designed to be reconstituted and injected by qualified healthcare professionals for gradual correction of facial volume loss, shallow to deep wrinkles, and contour deficiencies. Each vial contains a total of 365 mg of powder composed of poly-L-lactic acid, sodium carboxymethylcellulose, and mannitol. After reconstitution, the product acts as a biostimulatory dermal filler that triggers neocollagenesis in the deep dermis and subcutaneous tissues, providing progressive volume restoration and skin tightening. Training and distributor materials describe aesPlla as a CE-marked Class III medical device indicated for immune-competent adult patients, with visible improvements from around 4 weeks after treatment and effects that can last approximately 2–3 years when used in multi-session treatment protocols.
Bnefits
Poly-L-lactic acid (PLLA)–based collagen stimulator that induces gradual neocollagenesis rather than providing only immediate volumisation
Designed to restore lost volume and improve skin firmness, elasticity, and texture with natural-looking results
Long-lasting effects, with many clinical protocols and educational materials describing results that can persist for approximately 2–3 years after a treatment course
Progressive, subtle improvement over weeks to months, reducing the appearance of shallow to deep facial wrinkles and folds
Can be used on multiple facial areas (e.g. cheeks, temples, jawline, nasolabial folds, marionette lines) and selected body areas under professional protocols
Formulated with biocompatible and biodegradable synthetic polymer (PLLA) that is gradually resorbed by the body
Single vial (365 mg powder) format facilitates dose calculation and preparation for one treatment regimen
CE-marked Class III medical device in the EU and intended for use only by trained healthcare professionals
Indications
Biostimulatory treatment of shallow to deep nasolabial fold contour deficiencies in immune-competent adults, as described in distributor product information
Intended exclusively for professional use in authorised medical and aesthetic settings, with sale in some EU countries restricted to healthcare professionals, clinics, pharmacies, and authorised distributors.
Poly-L-lactic acid (PLLA) biostimulatory powder for reconstitution; Class III medical device for facial and body volume restoration
Correction of shallow to deep facial wrinkles and folds, including marionette lines and other deep dermal deficiencies
Restoration of facial volume in areas such as cheeks, temples, jawline/mandibular line, and chin, addressing sagging and volume loss
Treatment of selected atrophic scars, including acne scarring, under appropriate professional protocols
Use as a collagen stimulator for general facial rejuvenation and contouring in adults (typically patients aged 30 years and above) when administered by qualified professionals
Some training and marketing materials also describe off-face applications (e.g. décolletage, upper arms, thighs, buttocks, cellulite) under specialist protocols; these uses remain restricted to healthcare professionals in relevant regulatory jurisdictions
Composition
Total powder content per vial: 365 mg
Poly-L-lactic acid (PLLA): 150 mg
Sodium carboxymethylcellulose (CMC): 90 mg
Mannitol: 125 mg
PLLA – biodegradable, biocompatible synthetic polymer acting as the primary collagen-stimulating component
Sodium carboxymethylcellulose – thickener, stabiliser, and binder in the lyophilised powder matrix as described in training material
Mannitol – excipient to support lyophilisation and powder stability
Formulation
Sterile, absorbable poly-L-lactic acid (PLLA) dermal filler supplied as lyophilised powder for suspension
Injectable poly-L-lactic acid powder intended for reconstitution with sterile water for injection or normal saline prior to administration
Each vial nominally corresponds to 365 mg of powder, typically reconstituted to a total volume specified in the preparation protocol (e.g. approximately 5–9 mL depending on protocol)
Designed for deep dermal, subdermal, or subcutaneous injection using needle or cannula techniques, as per training guidance
Class III medical device in the European Union (collagen-stimulating dermal filler based on PLLA)
Packaging
Box containing 1 glass vial of aesPlla powder (365 mg total powder content per vial)
Vial intended to be reconstituted prior to use and used for a single patient according to professional protocols
Outer packaging and labelling indicate aesPlla as an injectable poly-L-lactic acid (PLLA) dermal filler for professional use only
Usage
aesPlla must be reconstituted and administered only by suitably qualified healthcare professionals experienced in injectable collagen stimulators.
Training materials describe reconstitution by adding sterile water for injection or normal saline to the vial, followed by shaking/agitation to ensure complete hydration of the lyophilised powder.
Manufacturer training content describes adding approximately 9 mL of sterile water or normal saline to the vial, shaking, and allowing the vial to stand for at least about 30 minutes to achieve full hydration before strong agitation immediately prior to injection.
Some distributor protocols describe reconstitution with 5 mL of sterile water for injection using an 18G needle, with a recommended dissolving time of up to approximately 3 hours and use within 72 hours of reconstitution; the exact protocol should follow the current official instructions supplied with the product.
Recommended injection planes in distributor protocols include deep dermis, lower dermis, and/or hypodermis using linear thread or similar techniques, depending on the treatment area.
Treatment is generally delivered as a series of sessions (often 3–4 treatment sessions, spaced around 4–6 weeks apart) based on patient needs and practitioner protocols.
Aftercare recommendations in clinic protocols commonly include massaging the treated area (e.g. 5 minutes, 5 times per day, for 5 days) to help distribute the product evenly and support collagen stimulation, as well as avoiding excessive heat, UV exposure, and strenuous exercise for a short period after treatment.
Clinicians should always follow the most recent aesPlla product instructions for use (IFU), local regulatory guidance, and their own clinical training when preparing, injecting, and managing post-treatment care.
Contraindications
Active inflammation or infection in or near the proposed treatment area, according to aesPlla training material.
Known hypersensitivity or allergy to any of the components of the product (poly-L-lactic acid, sodium carboxymethylcellulose, mannitol).
Pregnancy, breastfeeding, or patients under 18 years of age, as listed in training contraindication slides.
Patients with a known history of or susceptibility to keloid formation or hypertrophic scarring.
Use in or near the periorbital area and lips is specifically contraindicated in aesPlla training material.
Product information for cellulite indications states that aesPlla should not be injected into the gluteal (banana) fold.
Any additional contraindications or restrictions stated in the latest official instructions for use or local regulatory guidance must be observed.
Adverse Effects
Not publicly listed (no formal, product-specific adverse reaction table or SmPC-equivalent document has been located in publicly accessible manufacturer or regulatory sources; general dermal filler risks such as swelling, bruising, pain, nodules, and rare vascular events are described in clinical practice resources but are not provided as an official aesPlla adverse event listing).
Storage Conditions
Training materials state that aesPlla should be stored at room temperature, kept dry, and protected from sunlight, and must not be frozen.
Distributor product pages specify storage in a temperature range such as approximately 2 °C to 25 °C, protected from direct light, and not used after the expiry date indicated on the packaging.
Vials should be stored in their original packaging until use and handled in accordance with the manufacturer’s instructions and any applicable local regulations for medical devices.
Duration
Clinic and training materials typically describe a treatment course consisting of approximately 3\u20134 sessions administered at intervals of about 4\u20136 weeks, with collagen stimulation and volumising effects that can last for roughly 2\u20133 years after the final session before retreatment may be considered.
Onset
Visible results are generally reported from around 4 weeks after injection, with progressive improvement over subsequent weeks and months as new collagen is formed.
