1. Product name: Polycaprolactone Injectable Implant
  2. Brand name: GOURI, NEOME, BELLUXI
  3. Model name: DLMR01
  4. Composition: Polycaprolactone(PCL) 21%
  5. Intended purpose: This device is intended to be used for facial tissue augmentation for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds.
    This device is intended for non-medical purpose.
  6. Indication: It is indicated to be injected into mid-to-deep dermal implantation to correct moderate to severe facial wrinkles and folds.
  7. Expected performance: It can achieve improvement (More than grade 1) in patient satisfaction with the aesthetic results of the CFGS/GAIS in the satisfaction survey after treatment
  8. Expected resorption period: This device is wholly absorbed into and excreted from the body around 12 weeks.
  9. Directions for the Use
    1. Contraindication
      Do not use the Polycaprolactone Injectable Implant in the following cases :
      1. Consumers who are pregnant or breastfeeding (safety and effectiveness have not been established in this population).
      2. Consumers with active malignancy (cancer) or that currently undergoing cancer treatment, including chemotherapy, radiotherapy, immunotherapy, or other antineoplastic therapies.
      3. Consumers who showed anaphylaxis to raw materials of filler
      4. Consumers who have history of serious allergy or anaphylaxis
      5. Consumers with bleeding disorders or those taking thrombolytic agents or anticoagulants
      6. Consumers receiving NSAIDs, coagulation inhibitors, anticoagulants, immunosuppressants
      7. Consumers who have allergic disease, autoimmune disease, sarcoid granulomatous pathology, Osler’s endocarditis
      8. Consumers with serious allergies, anaphylaxis
      9. Consumers who tend to have hypertrophic scars
      10. Consumers with a history of dermal streptococcal disease
      11. Consumers who have inflammatory or infected skin.
      12. Consumers who are hypersensitive to polycaprolactone
    2. Warning:
      1. Do not use this product in conjunction with laser treatment, chemical peeling, or other skin resurfacing procedures.
      2. Wearing makeup within 12 hours after injection is not recommended. Avoid prolonged exposure to sunlight, UV rays, gel or saunas for 2 weeks following the injection.
      3. Until any edema or sensation of heat at the injection site disappears, the patient should avoid exposure to extreme temperatures.
      4. Avoid injecting to the part where permanent implant was placed.
      5. If inflammation reaction persists for more than a week or other side-effects appear, get immediate advice of a medical professional.
    3. Undesirable side effects
      The following side effects may occur after injection of the Polycaprolactone Injectable Implant (GOURI, NEOME, BELLUXI). Side effects are classified according to severity and expected frequency based on clinical experience with this device and similar polycaprolactone-based dermal fillers.
      Very common side effects (≥ 1/1,000 patients) – usually mild to moderate and transient:
      • Bruising / hematoma
      • Redness
      • Swelling / edema
      • Pain or tenderness at the injection site
      • Itching
    4. Common side effects (≥ 1/100,000 to < 1/10,000 patients):
      • Rash
      • Skin discoloration
      • Induration (hardening of the skin)
      • Small lumps / nodules
    5. Uncommon or rare side effects (< 1/1,000,000 patients) – may require medical attention:
      • Inflammation or infection (including redness with heat/red fever, edema accompanied by pain or cut wound)
      • Abscess formation
      • Hypersensitivity or oversensitive (allergic) reaction
      • Local inflammation, enlarged lymph nodes, tumor-like formations, discomfort, persistent pain, or fever
  10. Manufacturer:
    DEXLEVO INC.
    505, 632, Seobusaet-gil, Geumcheon-gu, Seoul, Korea
    www.dexlevo.co.kr
    TEL.: +82-2-6952-8770
    FAX.: +82-2-2138-8776
  11. EU Authorized Representative:
    CMC Medical Devices & Drugs S.L.
    C/ Horacio Lengo n18 C.P 29006 Málaga-Spain
    TEL.: +34 951 214 054
    Email: info@cmcmedicaldevices.com