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510(k) K243166

Dermalage by Infection Elimination Solutions, LLC — Product Code FRO

K243166 is an FDA 510(k) premarket notification submitted by Infection Elimination Solutions, LLC for the device "Dermalage". The FDA issued a decision of Substantially Equivalent on August 27, 2025. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2025
Date Received
September 30, 2024
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

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FDA data resources