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510(k) K213598

LUOFUCON Collagen Wound Dressing by Huizhou Foryou Medical Devices Co., Ltd. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2022
Date Received
November 15, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Huizhou Foryou Medical Devices Co., Ltd.

  • K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (November 19, 2025)
  • K240809 — LUOFUCON® Silver Collagen Dressing (December 16, 2024)
  • K242856 — LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ (November 13, 2024)
  • K240485 — LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® (October 7, 2024)
  • K232796 — LUOFUCON® Collagen Particles (Collagen Wound Dressing) (April 25, 2024)
  • K223360 — LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam (March 27, 2024)
  • K221110 — LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling (January 4, 2024)
  • K223359 — LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing (December 21, 2023)
  • K211123 — LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel (April 22, 2022)
  • K210718 — LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gell (March 23, 2022)

Other clearances for product code KGN

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  • K252673 — LacertaMatrix (December 22, 2025)
  • K253339 — Theracor (December 22, 2025)
  • K250864 — MatriDerm pluS+ Bi-Layer (December 19, 2025)
  • K242100 — SurgiAid Collagen Wound Dressing (HA) (October 16, 2025)
  • K252001 — Collagen Wound Dressing (October 10, 2025)
  • K250397 — Helios Dermal Scaffold (August 15, 2025)
  • K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (July 16, 2025)