Restylane Kysse 1x1ml
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.
Restylane Kysse is Galderma's OBT™ gel designed specifically for the lip. Its rheological balance — G′ 160 Pa with a deformability of 908 % — aims to provide volume and definition while maintaining lip mobility during speech and smiling. It is applied in the submucosal plane and also covers the upper perioral rhytides.
- Cross-linked HA 20 mg/ml
- Lidocaine 3 mg/ml (0.3 %)
- Technology OBT™ / XpresHAn™
- Contents 1 syringe × 1.0 ml
- Needles 2 × 30G ½" UTW
Composition and technology
- Cross-linked hyaluronic acid: 20 mg/ml, of non-animal origin, cross-linked with BDDE (1,4-butanediol diglycidyl ether) in phosphate buffer solution at pH 7.
- Lidocaine hydrochloride: 3 mg/ml.
- OBT™ technology: continuous, flexible, non-particulate gel. Kysse occupies the second-lowest firmness step of the OBT family, ahead only of Refyne.
- Rheological profile: G′ 160 Pa at 0.1 Hz and deformability (xStrain) of 908 %. The combination of low firmness and very high flexibility is what defines its labial use: enough support for volume, without perceptible stiffness during facial expression.
Position within the range: NASHA and OBT
The entire Restylane range is built on two different gel technologies. Choosing between them is the first clinical decision of the treatment.
NASHA® (Non-Animal Stabilized Hyaluronic Acid): firm, particulate gels that retain the long hyaluronic acid chains with minimal cross-linking. High resistance and very low tolerance to deformation: projection, definition and structural support in areas that must hold their shape.
OBT™ (Optimal Balance Technology, called XpresHAn Technology™ in the US market): soft, flexible gels with a variable degree of cross-linking. Low to intermediate resistance and high tolerance to deformation: the gel follows the movement of the tissue, so it is intended for dynamic and expressive areas.
| NASHA — firmness and projection | G′ 416–799 Pa · deformability 7–19 % |
|---|---|
| Restylane / Classyc Lidocaine | HA 20 mg/ml · G′ 701 Pa · 7 % — wrinkles in the mid dermis, lips |
| Restylane Lyft Lidocaine | HA 20 mg/ml · G′ 799 Pa · 17 % — cheekbones, mid third of the face, dorsum of the hands |
| Restylane Eyelight | HA 20 mg/ml — infraorbital hollowing, supraperiosteal plane |
| Restylane Skinboosters Vital / Vital Light | HA 20 and 12 mg/ml — skin quality and hydration, without volumetric purpose |
| OBT / XpresHAn — flexibility and expression | G′ 70–271 Pa · deformability 761–1,442 % |
| Restylane Refyne | HA 20 mg/ml · G′ 70 Pa · 1,442 % — moderate wrinkles and folds |
| Restylane Kysse | HA 20 mg/ml · G′ 160 Pa · 908 % — lips, submucosal plane |
| Restylane Volyme | HA 20 mg/ml · G′ 171 Pa · 930 % — malar volume, supraperiosteal or subcutaneous |
| Restylane Defyne | HA 20 mg/ml · G′ 271 Pa · 761 % — severe wrinkles and folds |
The G′ (0.1 Hz) and deformability (xStrain) values come from peer-reviewed literature (J Drugs Dermatol 2024;23(12):1332–1338). Galderma does not publish official rheological values.
Indications and treatment areas
To restore or increase lip volume and to correct the upper perioral rhytides.
- Lip body — volume augmentation
- Vermilion border and philtral columns — definition
- Upper perioral rhytides (barcode lines)
Injection that is too superficial can produce contour irregularities, palpable nodules or bluish discoloration (Tyndall effect).
Technique and treatment protocol
- Injection plane: submucosal in the lip body; from the mid dermis to the subcutaneous plane in the perioral rhytides and the philtral columns.
- Needles included: 2 units of 30G ½" ultra-thin wall. Blunt cannulas of 25–27G may be used as an alternative.
- Technique: linear retrograde threading or serial puncture, with low, constant pressure; light massage to shape after the deposit.
- Prior aspiration in accordance with standard clinical protocol; the perioral region is an area of significant vascular risk.
- Documented duration: in the pivotal study, 60 % of subjects maintained the improvement in lip volume at week 48; the improvement in perioral rhytides was maintained up to week 48 in the majority of subjects.
Technical data
| Manufacturer | Q-Med AB (Galderma) — Seminariegatan 21, SE-752 28 Uppsala, Sweden |
|---|---|
| Active substance | Cross-linked hyaluronic acid 20 mg/ml, non-animal origin |
| Anaesthetic | Lidocaine hydrochloride 3 mg/ml |
| Cross-linker | BDDE |
| Technology | OBT™ (XpresHAn Technology™) |
| Vehicle / pH | Phosphate buffer solution, pH 7 |
| Rheology | G′ 160 Pa · deformability 908 % |
| Presentation | 1 pre-filled syringe of 1.0 ml |
| Needles | 2 × 30G ½" ultra-thin wall (alternative: 25–27G blunt cannula) |
| Application plane | Submucosal (lip); mid dermis to subcutaneous (perioral) |
| Sterilisation | Moist heat (syringe contents) / ethylene oxide (needles) |
| Classification | CE-marked medical device (MDR 2017/745) |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: up to 25 °C. Protect from freezing and from sunlight.
- Do not use after the expiry date shown on the pack.
- Single-use product. Do not reuse or re-sterilise.
- The pack contains: 1 pre-filled syringe of 1.0 ml, 2 needles 30G ½" UTW, instructions for use and traceability labels for the patient record.
Contraindications and warnings
Contraindications (Galderma instructions for use): known hypersensitivity to streptococcal proteins or to any component of the product; history of severe allergies or of an anaphylactic reaction; hypersensitivity to lidocaine or to amide-type local anaesthetics; porphyria; active skin inflammation or infection in the area to be treated.
Precautions and individual assessment: coagulation disorders or anticoagulant or antiplatelet therapy (increased risk of haematoma and bleeding at the puncture site); history of hypertrophic or keloid scarring; autoimmune disease; presence of permanent implants in the area.
Warnings: do not inject intravascularly or intramuscularly. Intravascular injection can cause embolisation, vascular occlusion, ischaemia, skin necrosis, visual disturbance, blindness or stroke. Aspiration before injecting and low, constant injection pressure are recommended. Do not mix the gel with other products.
Always consult the instructions for use included in the pack before application.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the manufacturer's official documentation (Restylane® Kysse™ instructions for use, Q-Med AB / Galderma). This data sheet does not replace the instructions for use accompanying the product.