Medical Device
Manufacturer

医疗美容·PLLA

GANA PH

Poly-L-lactic acid microparticles (1 %) carried in a cross-linked hyaluronic acid gel: immediate volume from the HA, then collagen formation induced by the PLLA, with correction by hyaluronidase still possible.

01 概览

PLLA + HA dermal filler

  • 规格1.2 ml prefilled syringe × 1 per box
  • 成分
    • Poly-L-lactic acid (PLLA) 10 mg/cc, average particle size 50 µm
    • Cross-linked hyaluronic acid gel 20 mg/cc
    • PLLA 1 % + HA 99 %
  • 成分类别PLLA
  • 注册3 项有效 · 韩国 · 俄罗斯
  • 产品目录2026 年 GANA R&D 产品目录,第 12–14 页

产品详情以 GANA R&D 产品目录发布的英文版显示。

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GANA PH — carton with a 1.2 ml prefilled syringe and needles

02 有据可查

本产品的注册信息

每一项注册均以 GANA R&D 为制造商,所有编号均可在主管机构的公开登记系统中核查。

注册名称司法管辖区注册授予日期范围核查
GANA PH 韩国 · MFDS 제허22-304 2022年5月16日 出口 公开登记→
GANA PH 俄罗斯 · Roszdravnadzor РЗН 2024/22794 2024年5月30日 — 公开登记→
PH PLUS (GANA PH+) 韩国 · MFDS 제허22-53 2022年1月24日 出口 公开登记→

俄罗斯 Roszdravnadzor 登记系统使用俄罗斯国家颁发的证书,俄罗斯境外的浏览器在打开记录前可能会显示安全警告。

制造商

  • MFDS 制造业许可GANA R&D Co., Ltd. · MFDS No. 4490 · 公开登记→
  • GMP 证书KCL-ABBA-19926 · 有效期至 2027年3月3日
  • 生产场所555 Dunchon-daero, Jungwon-gu, Seongnam-si 13215, Republic of Korea

03 摘自产品目录

产品详情

转载自 2026 年 GANA R&D 产品目录。仅供医疗专业人员参考;本说明不能替代随产品提供的使用说明书。

What is PLLA

Poly(L-lactide) is a biodegradable material with good bio-absorbability and biocompatibility. After degradation in the body, PLLA is excreted through metabolism and leaves no harmful residue. For these reasons PLLA is widely used in medicine: single-use infusion equipment, surgical sutures, drug-delivery carriers, tissue-engineering scaffolds, bone anchors, injectable microcapsules and microspheres, implants and elastomers for organ support.

Mechanism

  1. PLLA (poly-L-lactic acid) → immune reaction
  2. The polymer of lactic acid is taken up by macrophages
  3. Lactic acid → CO₂ + H₂O; the immune reaction activates fibroblasts to produce collagen

PLLA degradation: random enzymatic degradation reduces the molecular weight, then the low-molecular PLLA is phagocytosed by macrophages.

  • Freeze-dried PLLA has micropores
  • The micropores absorb water and the particles break down into small pieces
  • The broken PLLA particles induce a controlled inflammation
  • Which leads to collagen synthesis

PLLA replaces lost collagen and corrects the imperfection; the effect lasts more than two years.

GANA PH compared with HA and PLLA fillers

HA fillersPLLA fillersGANA PH
Duration1 year3 years3 years
MigrationYesNoNo
Collagen stimulationNoYesYes
Elimination by hyaluronidaseYesNoYes
SwellingNoYesNo
CorrectionYesNoYes
Dissolution with waterNot neededMany hours of waitingNot needed
Volume augmentationImmediateAfter 2 monthsImmediate
  • Drawbacks of existing PLLA fillers: initial swelling, initial volume loss, impossibility of correction, long dissolution time, a two-month lag before volume augmentation.
  • The main complaint about HA fillers: short duration.

Merits of GANA PH

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

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.

推荐剂量

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

注意事项

  • 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 产品组合

GANA R&D 的其他真皮填充剂

全部真皮填充剂→

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本产品的注册证书、使用说明书和技术文件可应经销商和诊所的要求提供。

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