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510(k) K252023

MiraChlor Antimicrobial Wound Solution by Letus Corporation — Product Code FRO

K252023 is an FDA 510(k) premarket notification submitted by Letus Corporation for the device "MiraChlor Antimicrobial Wound Solution". The FDA issued a decision of Substantially Equivalent on Mar 25, 2026. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 25, 2026
Date Received
Jun 30, 2025
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 for product code FRO

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  • K261646 — Redermax® Antibacterial Wound Matrix (Aug 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (Aug 11, 2026)
  • K261023 — Microdacyn Wound Irrigation Solution (Jun 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (Jun 24, 2026)
  • K261638 — Bonvadis® (Jun 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (Apr 7, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (Mar 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (Mar 11, 2026)

FDA data resources