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510(k) K233399

Microdacyn Wound Care Solution by Sonoma Pharmaceuticals, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2024
Date Received
October 4, 2023
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 Sonoma Pharmaceuticals, Inc.

  • K240510 — Microdacyn Hydrogel (November 8, 2024)
  • K173896 — Microcyn Antimicrobial Hydrogel (April 2, 2018)
  • K171935 — Alevicyn SG Antimicrobial Gel (December 1, 2017)
  • K172622 — Microcyn Antimicrobial Skin and Wound Cleanser (November 21, 2017)
  • K172851 — Microcyn Plus Antimicrobial Wound Care Solution (November 15, 2017)
  • K171727 — Hydrocleanse Antimicrobial Skin and Wound Care Solution (July 26, 2017)

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  • 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)
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