Medical Device
Manufacturer

Medicina Estética·PCL

Filler X

Polycaprolactone microspheres carried in a cross-linked hyaluronic acid gel: immediate volume from the HA, longer-lasting volume from new collagen, and correction with hyaluronidase remains possible.

01 De un vistazo

PCL + HA dermal filler

  • Presentación1.2 ml prefilled syringe × 1 per box, with needles
  • Composición
    • Polycaprolactone (PCL) microspheres, average particle size 50 µm
    • Cross-linked hyaluronic acid gel 20 mg/cc
    • Lidocaine 3 mg/cc (as labelled on the carton)
  • Familia químicaPCL
  • Registros3 activos · Corea del Sur · Rusia
  • CatálogoCatálogo de productos GANA R&D 2026, pág. 7–9

Los detalles del producto se muestran en inglés, tal como se publican en el catálogo de GANA R&D.

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Filler X — carton, 1.2 ml prefilled syringe and needles

02 Constancia oficial

Registros de este producto

GANA R&D figura como fabricante en cada entrada. Cada número puede comprobarse en el registro público de la autoridad.

Nombre registradoJurisdicciónRegistroConcedidoAlcanceComprobar
Filler X Corea del Sur · MFDS 제허23-426 17 mar 2023 Exportación Registro público→
GANA Filler X Rusia · Roszdravnadzor РЗН 2025/26343 19 nov 2025 — Registro público→
Filler-X PLUS (BFAVGAK PCL FILL) Corea del Sur · MFDS 제허22-52 24 ene 2022 Exportación Registro público→

El registro de Roszdravnadzor usa un certificado estatal ruso. Fuera de Rusia, el navegador puede mostrar una advertencia de seguridad antes de abrir la ficha.

Fabricante

  • Licencia de fabricación MFDSGANA R&D Co., Ltd. · MFDS No. 4490 · Registro público→
  • Certificado GMPKCL-ABBA-19926 · vigente hasta 3 mar 2027
  • Planta de fabricación555 Dunchon-daero, Jungwon-gu, Seongnam-si 13215, Republic of Korea

03 Del catálogo

Detalles del producto

Reproducido del catálogo de productos GANA R&D 2026. Para profesionales sanitarios; estas notas no sustituyen las instrucciones de uso que acompañan al producto.

A new generation of dermal filler

Filler X combines polycaprolactone microspheres with a cross-linked hyaluronic acid gel. The HA gel gives even, immediate volume; the PCL then stimulates the skin’s own collagen, so the result builds gradually and lasts longer than an HA-only filler. The product is fully resorbed by the body.

What is PCL

Polycaprolactone (PCL) is a biodegradable polyester with a low melting point of around 60 °C and a glass transition temperature of about −60 °C. It is widely used in medical devices and is compatible with a range of other materials.

  • IUPAC name(1,7)-polyoxepan-2-one
  • Other names2-oxepanone homopolymer · 6-caprolactone polymer
  • CAS number24980-41-4
  • Chemical formula(C₆H₁₀O₂)n
  • Density1.145 g/cm³
  • Melting point60 °C (140 °F)

How it works

Collagen is one of the main support structures of the skin, maintaining tightness, elasticity and suppleness. With age the skin gradually loses collagen, which leads to laxity, wrinkles and folds.

Filler X corrects lines and folds like a conventional filler and, in addition, stimulates collagen formation to treat an underlying cause of facial ageing. The effect is gradual and longer-lasting, for a natural result.

Filler X compared with HA and PCL fillers

HA fillersPCL fillersFiller X
Duration1 year2–4 years2–4 years
MigrationYesNoNo
Collagen stimulationNoYesYes
Elimination by hyaluronidaseYesNoYes
SwellingNoYesNo
CorrectionYesNoYes
  • Known drawbacks of conventional PCL fillers: initial swelling, initial volume loss, no possibility of correction.
  • The main complaint about HA fillers: short duration.

Merits of Filler X

  1. Even, long-lasting volume augmentation of more than four years: immediate volume from the cross-linked hyaluronic acid gel, later volume from the collagen formed around the PCL.
  2. Lower initial swelling, as the formulation contains no carboxymethyl cellulose.
  3. Immediate correction is possible with hyaluronidase.
  4. The injected PCL induces collagen synthesis, so the duration is much longer than HA fillers.
  5. Newly formed collagen prevents migration.

Collagen-stimulating fillers in the GANA range

GANA V / GANA X, GANA PH and Filler X are all collagen-stimulating fillers. Do not use these products on the forehead, lips or periocular area.

Dosis recomendada

  • Both nasolabial folds: 1–2 ml
  • Both cheeks: 2–6 ml
  • Chin: 1–3 ml
  • Nose: 1–2 ml

Precauciones

  • All collagen-stimulating dermal fillers start to form collagen in 4–6 weeks; plan the treatment accordingly.
  • Injected on the forehead or lips, a collagen-stimulating filler can form lumps. Do not use on the forehead, lips or periocular area.

04 Portafolio

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Los certificados de registro, las instrucciones de uso y la documentación técnica de este producto están disponibles para distribuidores y clínicas previa solicitud.

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