FDA 510(k)

Dermalage

N.º K: K243166 · 2025-08-27

SolicitanteInfection Elimination Solutions, LLC

Fecha de decisión2025-08-27

Código de productoFRO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dermalage is the device name listed in this FDA 510(k) record. The listed applicant is Infection Elimination Solutions, LLC. It received FDA 510(k) clearance on 2025-08-27 under 510(k) 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.

Preguntas frecuentes

What is the Dermalage?

Dermalage is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Infection Elimination Solutions, LLC. The 510(k) number is K243166.

When did Dermalage receive FDA 510(k) clearance?

Dermalage received FDA 510(k) clearance on 2025-08-27, under 510(k) number K243166.

Who is the listed applicant for Dermalage?

The FDA 510(k) record lists Infection Elimination Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Fuente oficial

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