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Teosyal RHA KISS with Lidocaine (2 x 0.7 ml)

Teosyal RHA KISS with Lidocaine (2 x 0.7 ml)

Teosyal

Dermal filler
  • CE Marked Class III medical device in the European Union/EEA and other CE Recognising markets, for injection in the perioral region including lips and oral commissures.
  • Manufactured by Teoxane SA under ISO 13485 Compliant quality management systems for medical devices.
  • Uses non Animal Origin hyaluronic acid with very low residual BDDE levels (<1 ppm) and defined crosslinking degree (<5%), in line with international safety and quality requirements for injectable HA fillers.
  • Supplied with eIFU and Summary of Safety and Clinical Performance (SSCP) referenced in accordance with EU MDR requirements.
  • Distributed by professional aesthetic wholesalers such as LPG Clinics Wholesale, which state that all products are CE or CPNP approved where appropriate.
Hyaluronic acid lip filler for dynamic lip reshaping and perioral wrinkles

Description

Teosyal RHA KISS with Lidocaine (2 x 0.7 ml) is a sterile, transparent, non-pyrogenic, viscoelastic gel of cross-linked, non-animal hyaluronic acid specifically designed for subtle lip reshaping and treatment of the perioral region. Part of Teoxane’s multi-award-winning RHA (Resilient Hyaluronic Acid) collection, RHA KISS is engineered to adapt to dynamic movements of the mouth while maintaining natural expression, volume and hydration. Each 0.7 ml prefilled syringe contains 23 mg/ml hyaluronic acid, cross-linked with BDDE, and 0.3% lidocaine hydrochloride to improve injection comfort. The filler creates volume to enhance and contour the lips, corrects asymmetries, and smooths fine lines and wrinkles around the mouth, including perioral rhytids and oral commissures. As a biodegradable implant, Teosyal RHA KISS is progressively resorbed over time, with an estimated lifetime of approximately 12–18 months when used according to the Instructions for Use. It is CE-marked as a Class III medical device and intended exclusively for use by trained healthcare professionals.

Bnefits

  • Specifically developed for dynamic, subtle lip reshaping and contouring, providing natural-looking volume and definition.
  • Enhances lip volume for naturally fuller lips while respecting lip mobility and expression.
  • Targets the perioral region, helping to smooth fine lines and wrinkles in and around the lips, including perioral lines and oral commissures.
  • Delivers deep, long-lasting hydration to injected areas due to the high concentration of hyaluronic acid (23 mg/ml).
  • Resilient Hyaluronic Acid (RHA) technology allows the gel to adapt to facial movement, preserving skin vitality and softness.
  • Contains 0.3% lidocaine hydrochloride to reduce injection discomfort and improve patient experience during treatment.
  • Biodegradable and resorbable hyaluronic acid implant with an estimated durability of 12–18 months, depending on patient and treatment factors.
  • Supplied as ready-to-use prefilled syringes with appropriate fine needles (30G 1/2") and traceability labels, supporting safe and standardised clinical use.
  • Non-animal-origin, highly purified hyaluronic acid gel with very low residual BDDE (<1 ppm) and degree of crosslinking <5%.
  • Part of Teoxane’s CE-marked Teosyal RHA range, manufactured under stringent Swiss quality and ISO 13485 medical device standards.

Indications

  • Treatment of the perioral region, including the lips, philtrum and oral commissures, to correct wrinkles and cutaneous depressions.
  • Subtle augmentation and reshaping of lip volume and contour for naturally fuller lips.
  • Correction of mild to moderate linear facial wrinkles and skin creases around the mouth (perioral rhytids).
  • Softening of fine lines at the corners of the mouth and improvement of lip border definition.
  • Restoration of lip hydration and firmness in patients with age-related or lifestyle-related volume and moisture loss in the lip area.

Composition

  • Hyaluronic acid (sodium hyaluronate) 23 mg/ml, non-animal origin, average molecular weight >1 million Daltons.
  • Degree of crosslinking (BDDE-cross-linked HA): <5% (measured by NMR).
  • Lidocaine hydrochloride 0.3% by mass (local anaesthetic).
  • Phosphate buffer solution, pH 7.3, q.s. to 0.7 ml per syringe.
  • BDDE (1,4-butanediol diglycidyl ether) as crosslinking agent, residual level <1 ppm.

Formulation

  • Sterile, transparent, non-pyrogenic, viscoelastic gel of cross-linked hyaluronic acid with lidocaine for injectable use.
  • Resilient Hyaluronic Acid (RHA) technology designed to preserve long HA chains and provide elasticity adapted to dynamic lip movements.
  • Hyaluronic acid concentration: 23 mg/ml.
  • Lidocaine hydrochloride: 0.3% by mass (3 mg/ml equivalent local anaesthetic content).
  • Biodegradable implant progressively resorbed over time, with average lifetime 12–18 months depending on skin type, area, injected volume and lifestyle.
  • Non-animal-origin HA, crosslinked with BDDE under Teoxane’s preserved network technology, manufactured in Switzerland.

Packaging

  • Outer carton containing 2 prefilled glass syringes of Teosyal RHA KISS, each with 0.7 ml of gel.
  • For each syringe, the box includes two sterile 30G 1/2" (13 mm) needles from approved suppliers (e.g. TSK or Terumo).
  • Two traceability labels per syringe (one for the patient and one for the practitioner’s medical records).
  • Sterile blister pack for syringes and needles.
  • Carton labelled with product name, batch/lot number, expiry date, CE mark, storage conditions and manufacturer details.

Usage

  • For professional use only: TEOSYAL RHA KISS must be administered exclusively by well-trained, qualified healthcare professionals who are authorised under local regulations and experienced in hyaluronic acid filler injection and facial anatomy.
  • Before treatment, obtain a complete medical history including allergies (especially to hyaluronic acid, lidocaine or other amide-type local anaesthetics), autoimmune diseases, cardiac or hepatic disorders, epilepsy, porphyria, bleeding disorders, medications (e.g. anticoagulants, beta blockers), previous aesthetic treatments and history of severe allergy/anaphylaxis.
  • Assess the perioral region and lips, define realistic treatment goals with the patient, explain expected outcomes, potential side effects, contraindications and precautions, and obtain informed consent.
  • Inspect packaging before use: do not use if blister or syringe is damaged, opened prematurely, past expiry date, or if the gel appears cloudy, separated, contains bubbles or particulates.
  • Store and handle under aseptic conditions. Disinfect the treatment area thoroughly with an appropriate antiseptic solution and use sterile gloves and equipment.
  • Mount a supplied sterile 30G 1/2" needle (or an appropriate alternative sterile needle or verified compatible cannula, e.g. 25G) securely onto the luer-lock syringe following the instructions. Do not over-tighten or apply lateral force.
  • Expel any air bubbles and prime the needle by gently depressing the plunger until a small droplet appears at the tip.
  • Depending on the area to be treated, inject slowly at variable depths: into the dermis, subcutaneously, into the subdermis, or into the submucosa of the red lips, as guided by the Instructions for Use and clinical judgement.
  • Use appropriate injection techniques (e.g. serial puncture, linear threading, fanning, small bolus injections) according to the indication, anatomy and desired result. The healthcare professional selects the technique and volume based on individual needs.
  • Avoid injecting into or close to blood vessels or nerves. Inject slowly with minimal pressure and, where clinically appropriate, aspirate according to local practice to help reduce the risk of intravascular injection.
  • Do not inject into the most superficial layer of the skin (epidermis) or at depths other than those recommended in the IFU, and do not mix in the same syringe with other products.
  • Do not exceed a total of 6 ml per treatment session across all sites; for lip indications specifically, a maximum of 2 ml per session is recommended.
  • After injection, stop injecting before withdrawing the needle or cannula to avoid product reflux, then gently massage the treated areas to ensure uniform distribution, avoiding excessive pressure.
  • At the end of the session, discard any remaining unused product; the syringe and needles are single-use only and must not be re-sterilised or reused. Dispose of them in approved sharps containers.
  • Prior to treatment, advise patients to avoid high doses of vitamin E, aspirin, NSAIDs or anticoagulants in the week before injection where medically appropriate, to reduce the risk of bruising (in accordance with their prescribing physician’s advice).
  • Post-treatment, instruct patients not to wear make-up on treated areas for approximately 12 hours and to avoid dental treatments, other aesthetic procedures, extended sun or UV exposure, and extreme temperatures (intense cold, sauna, hammam, etc.) for about two weeks after injection.
  • Warn patients about signs of vascular compromise (skin whitening or marbling, severe pain, numbness) and instruct them to seek immediate medical attention if such symptoms occur. If any sign appears during injection, stop injection and implement appropriate management protocols.
  • Provide the patient with an implant card and retain traceability labels in the medical record. Inform them of the device details and how to report any adverse events.

Contraindications

  • Patients with cutaneous disorders, inflammation or infection at or near the treatment site; injection procedures may reactivate latent or subclinical herpes infections.
  • Known hypersensitivity to hyaluronic acid, or a history of severe allergy or anaphylactic shock.
  • Patients with autoimmune diseases.
  • Pregnant or breastfeeding women.
  • Patients younger than 18 years of age.
  • Because of the presence of lidocaine: known hypersensitivity to lidocaine and/or other amide-type local anaesthetic agents.
  • Patients with certain cardiac diseases and/or those undergoing treatment for heart conditions (e.g. beta-blockers), as specified in the IFU.
  • Patients with hepatocellular insufficiency and/or undergoing treatment for liver disease.
  • Patients suffering from epilepsy or porphyria.
  • Combination with other aesthetic procedures (such as peeling, laser treatment or ultrasound-based treatment) in the same area at the same time is not recommended; follow IFU guidance for sequencing.
  • Injection in the most superficial skin layer (epidermis), or injection into or close to a blood vessel or near a nerve, is strictly contraindicated.

Adverse Effects

  • Common, usually mild and self-resolving injection-site reactions (≥1/100): pain at the injection site, tenderness, redness/erythema, bruising/haematoma with potential bleeding or blister formation, swelling/oedema, firmness/induration, lumps or bumps (including papules), itching.
  • Less common complications (≥1/1,000 to ≤1/100): dyschromia/discoloration, inflammatory reactions (possibly with local hyperthermia), infection (localised or general, including abscesses), loss of sensitivity around the injected area or temporary paraesthesia (possibly associated with transient movement impairment), allergic/hypersensitivity reactions (including dermatitis allergy, urticaria), nodules (possibly granulomas), implant migration.
  • Rare but serious adverse events (≤1/1,000) reported for HA fillers and in Teosyal post-market surveillance: immediate hypersensitivity up to angioedema or anaphylactic shock; inadvertent injection in or near a blood vessel leading to embolisation, vascular occlusion, ischaemia and skin/tissue necrosis.
  • Extremely rare but severe events (about 1/1,000,000) related to vascular occlusion, such as vision impairment (temporary or permanent), cerebral ischaemia/haemorrhage or stroke, potentially leading to serious disability or death, particularly when injected in high-risk areas (e.g. nose, glabella).
  • Other non-serious reactions reported with very low frequency (<1/100,000): headache/neuralgia, fibrosis, cellulitis, scarring and telangiectasia.
  • As with any injectable treatment, vasovagal responses (dizziness, faintness or syncope) may occur in susceptible individuals.

Storage Conditions

  • Store between 2°C and 25°C, away from direct sunlight.
  • Keep the product in a storage area that does not damage or deform the packaging, and check that there are no visible signs of damage before use.
  • Do not use if the packaging is damaged, unintentionally opened before use, or if the recommended storage conditions have not been respected.
  • Do not use after the expiry date indicated on the product label.
  • Do not use if the content of the syringe shows signs of separation, bubbles or cloudiness.
  • The syringe and needles are supplied sterile for single use only; do not re-sterilise or reuse. Discard all remaining unused product and used devices in appropriate sharps and clinical waste containers.
  • Keep out of the sight and reach of children.

Duration

TEOSYAL RHA KISS is a biodegradable implant with an estimated lifetime between 12 and 18 months, depending on factors such as skin type, wrinkle severity, injection area, injected volume, and the patient\u2019s physiology and lifestyle.

Onset

Volume restoration, contour enhancement and wrinkle correction are visible immediately after injection, with final results becoming more apparent once initial swelling and redness resolve, typically within a few days to about 2 weeks.

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