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FDA 510(k)

Dermalage

K-Number: K243166 · 2025-08-27

ApplicantInfection Elimination Solutions, LLC
Decision Date2025-08-27
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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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