Lumifil L-Max (1x1ml)

What it is

Lumifil L-Max is a sterile, pyrogen-free physiological gel of cross-linked hyaluronic acid (20 mg/ml) of non-animal origin, with added lidocaine hydrochloride (3 mg/ml). It is colourless, odourless and highly viscous and is supplied in a single-use syringe.

Intended use (per instructions for use)

L-Max is used for the correction of moderate to severe facial wrinkles and folds and age-related midface contour deficiencies, and is injected into the deep layer of the dermis. Lumifil with lidocaine is indicated for correction of facial wrinkles and folds and for facial tissue augmentation by injection into the dermal layer of the skin; the lidocaine provides pain relief during treatment. All models are indicated only for patients over 21 years of age.

Composition

Cross-linked hyaluronic acid 20 mg/ml, lidocaine hydrochloride 3 mg/ml, phosphate buffered saline pH 7 q.s.

Treatment

• Contents: 1 pre-filled 1 ml syringe and 2 sterile needles (1 × 25G and 1 × 27G).
• Injection: deep dermis, using a linear threading technique or a series of punctual injections. Keep the product at room temperature for 30 minutes before injection and press the plunger until a small drop is visible at the needle tip. Inject slowly. The amount per wrinkle depends on its severity. Massage the area lightly after injection; touch-up can be done immediately or a few weeks later.

Important to know

Do not inject into the eye contours (eye circle or eyelids) or intravascularly. Do not use in pregnant or breastfeeding women, in people under 21 years of age, in case of known hypersensitivity to hyaluronic acid, a tendency to develop hypertrophic scarring, together with laser therapy, chemical peeling or dermabrasion, or in areas with inflammatory or infectious skin processes. Do not use in patients with bleeding disorders or who have had thrombolytics, anticoagulants or platelet aggregation inhibitors in the preceding 2 weeks, and do not inject into an area where there is an implant or mix with other products. Consider the total dose of lidocaine if dental block or topical lidocaine is used concurrently; use lidocaine with caution in epilepsy, impaired cardiac conduction, severely impaired hepatic or renal function and in patients receiving other local anaesthetics. If the skin turns whitish (blanching), stop the injection immediately and massage the area until it returns to normal colour. Possible adverse events: inflammatory reactions (redness, swelling, tenderness, which may last for two weeks), nodules or indurations, haematomas, discolouration and weak filling effect; glabellar necrosis, abscess formation, granuloma and hypersensitivity have been reported in the literature. Single-use; do not re-sterilise. Do not use if the package is opened or damaged.

Storage and shelf life

Store at 1–30 °C, protected from direct sunlight and freezing. Shelf life 3 years from the date of manufacture. Moist heat sterilised (needles sterilised with ethylene oxide).

Documentation and traceability

CE-marked medical device (MDD 93/42/EEC; notified body 2265 for the product and 0068 for the needles). Manufacturer: BNC KOREA, Inc., Daegu, South Korea. See the attached Norwegian instructions for use (BC translation rev. 01, 06.10.2026, source 2024.02 / Rev.No.02).

Composition: cross-linked hyaluronic acid 20 mg/ml (synthesised from sodium hyaluronate and 1,4-butanediol diglycidyl ether, BDDE), lidocaine hydrochloride 3 mg/ml, phosphate buffered saline pH 7 q.s. Non-animal origin. 1 pre-filled 1 ml syringe.

Inject into the deep dermis using a linear threading technique or a series of punctual injections, with the enclosed needles (1 × 25G and 1 × 27G). Keep the product at room temperature for 30 minutes before injection and inject slowly. If the skin turns whitish (blanching), stop the injection and massage the area until it returns to normal colour. See the attached instructions for use.