Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® XL for the Restoration and/or Augmentation of Facial Volume

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

• 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).
• Subject with a scar, moles or anything on the face which might interfere with the evaluation
• 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
• Subject having received injection with a resorbable filling product in the face area within the past 18 months prior to inclusion
• 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, …)
• History of or active autoimmune disease/immune deficiency
• Suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…)
• Prone to hypertrophic scars
• History of allergy to hyaluronic acid or any of the product's components
• History of allergy to lidocaine or local anaesthesia of amide compounds
• Known case of porphyria
• Pregnancy or lactation
• Taking medications and/or substances known to increase coagulation time (e.g., aspirin, ibuprofen, or herbal supplements) 10 days prior to treatment
• 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
• Untreated epilepsy
• Hypersensitivity to gram positive bacterial proteins as hyaluronic acid is produced by Streptococcus type bacteria.