Dermalage
K-Number: K243166 · 2025-08-27
ApplicantInfection Elimination Solutions, LLC
Decision Date2025-08-27
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Dermalage is a medical device manufactured by Infection Elimination Solutions, LLC. It received FDA 510(k) clearance on 2025-08-27 under approval number K243166. 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 Dermalage?
Dermalage is a medical device that received FDA 510(k) clearance on 2025-08-27. It is manufactured by Infection Elimination Solutions, LLC. The 510(k) number is K243166.
When was Dermalage approved by the FDA?
Dermalage received FDA 510(k) clearance on 2025-08-27, under approval number K243166.
What company makes Dermalage?
Dermalage is manufactured by Infection Elimination Solutions, LLC.
What is the FDA product code for Dermalage?
The FDA product code for Dermalage is FRO. This falls under the Anesthesiology category.
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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.