Home / 510(k) Clearances / K141382

510(k) K141382

BIOS KING BIOCELLULOSE FILM by Coreleader Biotech Co., Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2015
Date Received
May 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Coreleader Biotech Co., Ltd.

  • K151204 — HEMO-Bandage (July 31, 2015)
  • K123394 — CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING (June 6, 2013)
  • K111578 — CORELEADER COLLA-ALGI FIBER MODEL CAW (September 23, 2011)
  • K111733 — CORELEADER SCAR-DIMMER (September 22, 2011)
  • K102944 — CORELEADER HEMO-PAD MODEL CPII 02030 (September 7, 2011)
  • K102942 — CORELEADER ALGIPLASTER MODEL AP 050501 (June 22, 2011)
  • K102946 — CORELEADER COLLA-PAD MODEL CS 03030 (May 20, 2011)
  • K102943 — CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 (April 12, 2011)

Other clearances for product code FRO

  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)
  • K250890 — SBC1 Cream (January 12, 2026)
  • K252759 — revyve® Antimicrobial Skin and Wound Cleanser (January 8, 2026)
  • K251757 — Puracyn® Plus Antimicrobial Irrigation Solution (January 5, 2026)
  • K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber (December 19, 2025)
  • K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (November 19, 2025)
  • K250115 — Hemastyl(™) Wound Dressing (October 14, 2025)