Dispositivo KOS® XL para la restauración del volumen facial

Fecha de inicio: 16 de junio de 2025

Inclusion Criteria: * Females and males ≥ 22years of age * Signed informed consent by the subject * Subject with grade from 3 to 5 on the FVLS. * Ability to follow study instructions and likely to complete all required visits * Reliable methods of contraception which result in a low failure rate (i.e. less than 1 % per year) for women of childbearing potential, e.g. implants, injectables, combined oral contraceptives, some intrauterine -devices, sexual abstinence or vasectomized partner) for the entire study duration. Exclusion Criteria: 1. Using any new over-the-counter or prescription oral or topical, anti-wrinkle products within 30 days before enrolment or planning to begin using such products during the study (Subjects who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study). 2. Subject with a scar, moles or anything on the face which might interfere with the evaluation 3. Subject having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to inclusion 4. Subject having received injection with a resorbable filling product in the face area within the past 18 months prior to inclusion 5. Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …) 6. History of or active autoimmune disease/immune deficiency 7. Suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…) 8. Prone to hypertrophic scars 9. History of allergy to hyaluronic acid or any of the product's components 10. History of allergy to lidocaine or local anaesthesia of amide compounds 11. Known case of porphyria 12. Pregnancy or lactation 13. Taking medications and/or substances known to increase coagulation time (e.g., aspirin, ibuprofen, or herbal supplements) 10 days prior to treatment 14. Have a condition or be in a situation that, in the physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study 15. Untreated epilepsy 16. Hypersensitivity to gram positive bacterial proteins as hyaluronic acid is produced by Streptococcus type bacteria.