Dermalax Deep Plus (with Lidocaine)

Dermalax Deep Plus (with Lidocaine)

Dermalax

Medical device
  • CE Marked medical device (Dermalax family; specific notified body number reported by distributors, verification via IFU recommended).
  • Manufacturing under ISO 13485 Compliant quality management system (as reported by distributors and brand materials).
  • Complies with European medical device regulatory framework applicable to hyaluronic acid dermal fillers (legacy MDD 93/42/EEC / transition toward MDR, depending on lot and date).
  • Non Animal origin hyaluronic acid, purified and sterilized to meet medical Grade standards.
  • Biologic safety tested, including limits on endotoxin levels, residual cross Linking agents and impurities.
  • Intended for professional use only, in accordance with local medical device regulations in the country of use.
Hyaluronic acid dermal filler

Description

Dermalax Deep Plus is a CE-certified, monophasic, cross-linked hyaluronic acid dermal filler with lidocaine, designed for injection into the deep dermis or middle layer of the subcutis to correct moderate to deep wrinkles and folds and to restore or enhance facial volume and contours. The high-density HA gel provides long-lasting volumizing effects (typically around 12 months) while the 0.3% lidocaine content improves patient comfort during treatment. It is supplied as a sterile, pre-filled 1.1 ml syringe with 27G needles for use by trained medical professionals.

Bnefits

  • High-density, monophasic, cross-linked HA gel for strong volumizing and lifting effect
  • Targets moderate to deep wrinkles and folds including nasolabial folds and perioral lines
  • Effective for volumizing and shaping facial contours such as cheeks, chin, jawline and lips
  • Contains 0.3% lidocaine to significantly reduce injection discomfort
  • Smooth, cohesive gel with soft extrusion force for precise placement and natural-looking results
  • Non-animal origin hyaluronic acid with high biocompatibility and excellent biological safety
  • Long-lasting results, typically up to around 12 months depending on patient factors and treatment area
  • CE-certified manufacturing and quality system (medical device compliance and ISO-based QA)
  • Low impurity levels and controlled crosslinking for reduced risk of inflammatory reactions
  • Stable rheology that minimizes migration after injection and supports predictable outcomes

Indications

  • Correction of moderate to deep facial wrinkles and folds
  • Nasolabial folds (nose-to-mouth lines)
  • Perioral lines and lip border definition
  • Lip volumizing, fullness and pouting
  • Forehead and glabellar (frown) lines when appropriately indicated
  • Cheek volumizing and contouring
  • Chin and jawline contouring and volume restoration
  • Correction of mid-face volume loss and sunken or hollow areas (e.g. mid-cheek)
  • Restoration of eyebrow and temporal volume when injected by experienced practitioners

Composition

  • Stabilized, cross-linked hyaluronic acid 24 mg/ml (non-animal origin)
  • Lidocaine hydrochloride 0.3% (local anesthetic for pain reduction)
  • Phosphate-buffered saline / isotonic buffer solution
  • Trace excipients required to stabilize HA gel matrix (pyrogen-free, sterile, apyrogenic formulation)

Formulation

  • Supreme & pure, monophasic, cross-linked hyaluronic acid gel
  • High-density HA with cohesive, non-particulate structure
  • Non-animal origin, biodegradable and biocompatible soft tissue filler
  • Incorporated 0.3% lidocaine for improved treatment comfort
  • Sterile, pyrogen-free, isotonic gel for intradermal / subcutaneous injection

Packaging

  • 1 x 1.1 ml pre-filled, single-use glass syringe per box
  • Typically supplied with 2 x 27G sterile needles (single-use)
  • Sterile blister pack inside an outer carton
  • Shelf life typically 24 months from date of manufacture when stored correctly
  • Tamper-evident packaging with product identification, lot number and expiry date

Usage

  • Intended for use only by licensed, appropriately trained medical professionals experienced in dermal filler injection techniques.
  • Before treatment, obtain full medical history, assess indications, discuss expectations and obtain informed consent.
  • Cleanse and disinfect the treatment area using appropriate antiseptic technique; use sterile gloves and equipment.
  • Recommended injection depth: deep dermis and/or middle layer of the subcutis depending on indication and treatment area.
  • Use the supplied or equivalent 27G needle; verify integrity of syringe, needle connection and sterility before use.
  • Inject slowly with low, even pressure to ensure smooth deposition of the gel; avoid bolus injection in high-risk vascular areas.
  • For wrinkle correction, inject along or beneath the fold using linear threading, serial puncture or fanning techniques as appropriate.
  • For volumizing and contouring (cheeks, chin, jawline), deposit product in small aliquots on the correct anatomical plane, respecting facial vasculature.
  • Massage the treated area gently after injection to ensure even distribution and to smooth out palpable irregularities, avoiding excessive pressure.
  • Do not inject into blood vessels, intramuscularly, into areas of active inflammation, infection, or in previously injected sites with permanent fillers.
  • Use with caution in areas with high vascular risk (e.g. glabella, nose); adhere to established safety zones and techniques.
  • Discard any unused product after single-patient use; never resterilize or reuse syringe or needles.
  • Provide post-treatment advice: avoid makeup for several hours, avoid extreme heat/cold, intense exercise and alcohol for 24 hours, and avoid massage or pressure on the treated areas for a few days unless otherwise instructed.
  • Advise patients to report any signs of complications immediately, including severe pain, blanching, visual changes, or signs of infection.

Contraindications

  • Known hypersensitivity to hyaluronic acid or any of the excipients in the product.
  • Known hypersensitivity or allergy to lidocaine or other amide-type local anesthetics.
  • Patients with a history of severe allergic reactions or anaphylaxis.
  • Presence of active skin disease, inflammation, infection or herpes lesions at or near the intended injection sites.
  • Patients with uncontrolled autoimmune diseases or severe immune deficiency, unless judged appropriate by a specialist.
  • Pregnant or breastfeeding individuals (use is generally not recommended due to lack of sufficient safety data).
  • Patients with known bleeding disorders or those on significant anticoagulant / antiplatelet therapy that cannot be safely managed.
  • History of hypertrophic scarring or keloid formation in the proposed treatment area.
  • Previous permanent fillers or implants in the same area where interaction risk is uncertain.
  • Any contraindication listed in the official instructions for use (IFU) and local regulatory guidance.

Adverse Effects

  • Common, usually transient injection-site reactions: redness (erythema), swelling, tenderness, itching, warmth and mild pain.
  • Bruising or hematoma at the injection site.
  • Local edema or unevenness that generally resolves within days.
  • Temporary firmness or palpable nodules at or near the injection area, often improving with massage and time.
  • Rare delayed inflammatory reactions or hypersensitivity responses, potentially requiring medical management.
  • Rare granuloma or persistent nodule formation.
  • Very rare but serious complications related to intravascular injection or vascular compression, including skin blanching, ischemia, tissue necrosis, or visual compromise/vision loss in high-risk areas.
  • Infection or abscess formation if aseptic technique is not strictly followed.
  • Pain, dysesthesia or altered sensation in the treated area.
  • Any adverse events listed in the official IFU should be considered; patients must be advised to seek urgent medical attention if severe or unusual symptoms occur.

Storage Conditions

  • Store between 2°C and 25°C (36°F–77°F).
  • Protect from direct sunlight and keep in original outer carton until use.
  • Do not freeze; freezing can damage the gel structure and compromise safety and efficacy.
  • Store in a clean, dry environment away from contaminants.
  • Do not use after the expiry date printed on the packaging.
  • Do not use if packaging, blister, or syringe sterility is compromised (e.g. damaged, opened or contaminated).

Duration

Clinical effect generally lasts around 9\u201312 months or more depending on injection site, volume used, patient metabolism, lifestyle and skin condition; touch-up or maintenance treatments are usually scheduled annually or as clinically indicated.

Onset

Visible volumizing and wrinkle-filling results are immediate after injection, with final outcome typically evident after 1\u20132 weeks once initial swelling and potential bruising subside.

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