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FDA 510(k)

MiraChlor Antimicrobial Wound Solution

K-Number: K252023 · 2026-03-25

ApplicantLetus Corporation
Decision Date2026-03-25
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MiraChlor Antimicrobial Wound Solution is a medical device manufactured by Letus Corporation. It received FDA 510(k) clearance on 2026-03-25 under approval number K252023. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiraChlor Antimicrobial Wound Solution?

MiraChlor Antimicrobial Wound Solution is a medical device that received FDA 510(k) clearance on 2026-03-25. It is manufactured by Letus Corporation. The 510(k) number is K252023.

When was MiraChlor Antimicrobial Wound Solution approved by the FDA?

MiraChlor Antimicrobial Wound Solution received FDA 510(k) clearance on 2026-03-25, under approval number K252023.

What company makes MiraChlor Antimicrobial Wound Solution?

MiraChlor Antimicrobial Wound Solution is manufactured by Letus Corporation.

What is the FDA product code for MiraChlor Antimicrobial Wound Solution?

The FDA product code for MiraChlor Antimicrobial Wound Solution is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT07604636 Adjunctive Ozone Therapy for Residual Periodontal Pockets COMPLETED NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT07099482 "Ultrasound-Enhanced Propolis Therapy for Healing Diabetic Foot Wounds" NOT_YET_RECRUITING NCT07551297 Ozone Therapy After Open Flap Debridement in Periodontitis COMPLETED NCT07066254 The Mepilex Cesarean Delivery Trial NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025)

Related Devices (Code: FRO)

K160695Talymed SuspensionMarine Polymer Technologies, Inc. K160872PolyPlex Wound DressingGlobal Health Solutions, LLC K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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