Rejeunesse Deep (1 x 1.1 ml)

Rejeunesse

Dermal filler

Cross-linked hyaluronic acid filler for moderate to deep wrinkles and lip augmentation

CE Marked hyaluronic acid dermal filler (Class III medical device) according to information from distributors and product listings.
Manufactured in South Korea by Newmedic Co., Ltd. under medical device regulations applicable to hyaluronic acid fillers.
Uses proprietary purification and crosslinking technology (e.g., UPHEC / SMART Type processes) designed to reduce residual BDDE and endotoxin to very low levels.
Intended for professional medical use in accordance with international standards and local regulations for injectable dermal fillers.

CE Marked hyaluronic acid dermal filler (Class III medical device) according to information from distributors and product listings.
Manufactured in South Korea by Newmedic Co., Ltd. under medical device regulations applicable to hyaluronic acid fillers.
Uses proprietary purification and crosslinking technology (e.g., UPHEC / SMART Type processes) designed to reduce residual BDDE and endotoxin to very low levels.
Intended for professional medical use in accordance with international standards and local regulations for injectable dermal fillers.

Cross-linked hyaluronic acid filler for moderate to deep wrinkles and lip augmentation

Description

Rejeunesse Deep is a sterile, pyrogen-free, 100% cross-linked hyaluronic acid dermal filler from South Korea, designed for correction of moderate to deep facial wrinkles and for lip augmentation. The monophasic, viscoelastic gel contains non-animal hyaluronic acid (24 mg/ml) with 0.3% lidocaine to improve injection comfort. It is injected into the mid to deep dermis to restore volume, define contours, and enhance the lips, while maintaining a natural look in areas with high mobility such as the lips and nasolabial folds. The product is intended for professional use only in patients over 18 years of age who are not pregnant, breastfeeding, or allergic to any components.

Bnefits

Provides natural-looking volume and contouring for lips, nasolabial folds, and other areas of volume loss.
Formulated with 100% cross-linked, non-animal hyaluronic acid for longer-lasting results compared to non–cross-linked gels.
High viscoelasticity and cohesivity help maintain shape and reduce migration in high-mobility areas such as the lips.
Contains 0.3% lidocaine to reduce pain and discomfort during and immediately after injection.
Suitable for correction of moderate to deep wrinkles and folds, including nasolabial folds and marionette lines.
Can be used for lip enhancement to increase fullness, improve definition, and correct asymmetries.
UPHEC/SMART-type purification and crosslinking technology designed to minimise residual BDDE and endotoxin levels, enhancing safety.
Clinical effects are typically visible immediately after treatment and can last many months depending on patient factors and area treated.

Indications

Correction of moderate to deep facial wrinkles and folds (e.g., nasolabial folds, marionette lines).
Lip augmentation and contouring (increasing lip volume, defining vermilion border, correcting asymmetry).
Restoration of midface volume and contour in indicated areas (such as cheeks and chin) according to practitioner judgment.
General enhancement of facial contours where mid to deep dermal volume is required.
Adult patients (18+ years) seeking non-surgical aesthetic correction with hyaluronic acid fillers.

Composition

Hyaluronic acid (sodium hyaluronate) 24 mg/ml, cross-linked, non-animal origin.
Lidocaine hydrochloride 0.3% (3 mg/ml) as a local anesthetic.
Phosphate-buffered saline (physiological buffer solution).
Trace amounts of BDDE (1,4-butanediol diglycidyl ether) as the crosslinking agent, with residual levels reduced by proprietary purification technology.
Water for injections.

Formulation

Sterile, transparent, pyrogen-free, viscoelastic monophasic gel.
100% cross-linked hyaluronic acid of non-animal origin.
Contains 0.3% lidocaine for pain reduction during injection.
Designed for injection into the mid to deep dermis.
Single-use pre-filled syringe intended for professional medical use only.

Packaging

Box containing 1 pre-filled glass syringe with 1.1 ml of cross-linked hyaluronic acid gel.
Typically supplied with 1 or 2 sterile disposable needles (commonly 27G or similar, exact specification may vary by batch or market).
Sterile blister packaging for syringe and needles.
Package insert / instructions for use (IFU).
Traceability labels for medical records and patient documentation.

Usage

For professional use only: injections must be performed by a suitably trained and licensed healthcare professional experienced in dermal filler techniques.
Evaluate the patient’s medical history, indications, and expectations; obtain informed consent before treatment.
Clean and disinfect the treatment area thoroughly using appropriate antiseptic measures.
Rejeunesse Deep is injected into the mid to deep dermis using appropriate techniques such as linear threading, serial puncture, or fan techniques, depending on the area and desired outcome.
For moderate to deep wrinkles (e.g., nasolabial folds, marionette lines), inject along the length of the fold in the mid to deep dermis, depositing small aliquots of gel while withdrawing the needle or cannula.
For lip augmentation, inject into the body of the lip and/or vermilion border according to the practitioner’s design, taking care to avoid intravascular injection and overcorrection.
Inject slowly with gentle, even pressure and avoid high-pressure bolus injections.
Aspirate cautiously where clinically appropriate to reduce the risk of intravascular injection.
Massage the treated area gently after injection to ensure even distribution and smooth contour, unless contraindicated.
Do not overcorrect; it is safer to add more product at a follow-up visit than to inject excessive volume in one session.
Advise patients to avoid makeup, saunas, intense physical exercise, and exposure to extreme temperatures for at least 24 hours after treatment, or according to the IFU and local clinical protocol.
Always refer to and follow the full instructions for use (IFU) supplied with the product for detailed directions, warnings, and precautions.

Contraindications

Known hypersensitivity or allergy to hyaluronic acid, lidocaine, other amide-type local anesthetics, or any component of the formulation.
Patients with a history of severe anaphylactic reactions or multiple severe allergies.
Presence of active skin infection, inflammation, herpes, or other dermatologic disease at or near the intended injection site.
Autoimmune diseases or immunocompromised conditions, unless the treating physician determines that the benefits outweigh the risks.
Bleeding disorders, coagulation abnormalities, or current use of anticoagulant or antiplatelet medications that significantly increase bleeding risk, unless carefully evaluated by a physician.
Pregnancy and breastfeeding (not recommended due to lack of safety data).
Patients under 18 years of age.
Previous permanent fillers or foreign bodies in the same area, where there is a risk of interaction, unless carefully assessed by an experienced physician.
Any general contraindications to hyaluronic acid dermal fillers or local anesthetics as determined by the treating healthcare professional.
Do not inject into blood vessels, into areas with active inflammatory or infectious processes, or in regions where there is compromised blood supply.

Adverse Effects

Common, usually transient injection-site reactions such as redness (erythema), swelling (edema), tenderness, pain, itching, or warmth.
Bruising or hematoma at the injection site.
Temporary lumps, nodules, or unevenness in the treated area, often improving with massage or over time.
Transient firmness, induration, or palpable product in the treated area.
Skin discoloration or mild pigment changes around the injection area.
Delayed inflammatory reactions or hypersensitivity, such as prolonged swelling, erythema, or induration, which may require medical treatment.
Infection at the injection site if aseptic technique is not strictly followed.
Very rare but serious complications include intravascular injection leading to tissue ischemia or necrosis, or embolic events that may affect vision or lead to stroke; these require immediate emergency management by a qualified physician.
Allergic or toxic reactions to lidocaine (e.g., systemic manifestations of local anesthetic toxicity) in susceptible individuals.
Any unexpected, persistent, or severe adverse reaction should be evaluated promptly; refer to the official IFU for a full list of potential side effects.

Storage Conditions

Store in the original packaging to protect from light and contamination until use.
Keep at controlled room temperature as specified in the IFU (typically between 2 °C and 25 °C).
Do not freeze.
Protect from direct sunlight and excessive heat.
Do not use after the expiry date indicated on the packaging.
Use only if the syringe, blister, and packaging are intact and the gel appears homogeneous and free of visible particles.
Single-use medical device: do not resterilise, and do not reuse any opened or partially used syringe.

Duration

Effects are generally reported to last around 8\u201312 months, and in some patients up to approximately 12\u201318 months depending on the area treated, injection technique, metabolism, and lifestyle factors. Maintenance or touch-up treatments may be performed at the clinician\u2019s discretion to sustain results.

Onset

Visible improvement is usually immediate after injection due to the volumizing effect of the gel, with final results stabilising over several days as swelling subsides.