Revolax Fine Lidocaine 1x1.1ml
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
REVOLAX™ Fine with lidocaine is the most fluid gel in the range of monophasic fillers from Across Co., Ltd. (South Korea). With the same hyaluronic acid concentration as the rest of the line (24 mg/ml) but a lower degree of cross-linking, it is formulated for the superficial correction of fine lines using a 30G needle, in areas where a dense gel would be visible or palpable.
- Cross-linked HA 24 mg/ml
- Lidocaine 3 mg/ml (0.3 %)
- Contents 1 syringe × 1.1 ml
- Needles 2 × 30G
- Duration 9–12 months
Composition and technology
- Cross-linked hyaluronic acid: 24 mg/ml, of non-animal origin, obtained by bacterial fermentation.
- Lidocaine hydrochloride: 3 mg/ml (0.3 %), to reduce discomfort during injection.
- Cross-linking agent: BDDE. The manufacturer states that residual BDDE is removed by a prolonged dialysis process.
- Homogeneous monophasic structure: the gel is not fractionated into particles of different sizes. In the Fine variant the degree of cross-linking is the lowest in the range, which results in the lowest extrusion force and allows passage through a 30G needle.
- Manufacturing under ISO 9001 and ISO 13485 certification.
Position within the REVOLAX range
The three variants share the same hyaluronic acid concentration (24 mg/ml) and lidocaine concentration (0.3 %). What differentiates them is the degree of cross-linking and, with it, the density of the gel, the injection plane and the needle gauge supplied.
| Variant | Fine — the most fluid gel |
|---|---|
| Plane | Superficial to mid dermis |
| Needle | 2 × 30G |
| Indication | Fine lines, crow's feet, glabella, perioral and neck wrinkles |
| Duration | 9–12 months |
| Variant | Deep — intermediate density |
|---|---|
| Plane | Mid to deep dermis / superficial subcutaneous |
| Needle | 2 × 27G |
| Indication | Nasolabial sulcus, marionette lines, lips, chin, rhinomodelling |
| Duration | 12–18 months |
| Variant | Sub-Q — the densest gel |
|---|---|
| Plane | Deep subcutaneous |
| Needle | 2 × 25G |
| Indication | Structural augmentation of cheekbones, chin, mandibular angle and nasal dorsum |
| Duration | 12–18 months |
Indications and treatment areas
Injectable hyaluronic acid implant indicated for the correction of fine and superficial wrinkles in adult patients.
- Periorbital lines (crow's feet)
- Superficial glabellar and forehead lines
- Perioral wrinkles and barcode lines
- Superficial wrinkles of the neck and décolleté
- Hydration and definition of the lip contour
Technique and treatment protocol
- Injection plane: superficial to mid dermis.
- Needles included: 2 units of 30G, sterile and single-use.
- Technique: slow injection with constant pressure. Withdraw the needle while continuing to advance in linear retrograde injection or by fanning technique according to the indication.
- Aspiration prior to injection in accordance with standard clinical protocol to reduce the risk of intravascular injection.
- Manual moulding of the product after injection is recommended in order to even out the distribution.
- Do not apply immediately before or after laser, chemical peeling or dermabrasion.
- Single-use product: discard any product remaining in the syringe after the session.
Technical data
| Manufacturer | Across Co., Ltd. — South Korea |
|---|---|
| Active substance | Cross-linked hyaluronic acid 24 mg/ml, non-animal origin |
| Anaesthetic | Lidocaine HCl 3 mg/ml (0.3 %) |
| Cross-linker | BDDE |
| Structure | Monophasic gel, low cross-linking within the range |
| Presentation | 1 pre-filled syringe of 1.1 ml |
| Needles | 2 × 30G |
| Classification | CE-marked class III medical device |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: between 2 °C and 25 °C, protected from direct sunlight. Do not freeze.
- Do not use after the expiry date stated on the pack.
- Sterile single-use product. Do not reuse or re-sterilise.
- The pack contains: 1 pre-filled syringe of 1.1 ml, 2 needles 30G, instructions for use and traceability labels.
Contraindications and warnings
Contraindications: pregnancy and breastfeeding; under 18 years of age; known hypersensitivity to hyaluronic acid, to lidocaine or to amide-type local anaesthetics; tendency to hypertrophic or keloid scarring; active skin inflammation or infection in the treatment area (active acne, herpes); active autoimmune disease; porphyria.
Caution: do not apply in areas with pre-existing permanent implants. Avoid simultaneous application with laser, deep chemical peeling or dermabrasion. Assess individually in patients on anticoagulant or antiplatelet therapy and in patients with a history of severe allergic reactions.
Never inject intravascularly. Always consult the instructions for use included in the pack before treatment.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on documentation from the manufacturer Across Co., Ltd. and from the official distribution of the REVOLAX brand. This information sheet does not replace the instructions for use supplied with the product.