FDA 510(k)

Helios Dermal Scaffold

K-Number: K250397 · 2025-08-15

Decision Date2025-08-15

Product CodeKGN

DecisionSubstantially Equivalent

Device Summary

Helios Dermal Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Helios Biomedical, Inc.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K250397. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Helios Dermal Scaffold?

Helios Dermal Scaffold is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Helios Biomedical, Inc.. The 510(k) number is K250397.

When did Helios Dermal Scaffold receive FDA 510(k) clearance?

Helios Dermal Scaffold received FDA 510(k) clearance on 2025-08-15, under 510(k) number K250397.

Who is the listed applicant for Helios Dermal Scaffold?

The FDA 510(k) record lists Helios Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Helios Dermal Scaffold?

The FDA product code for Helios Dermal Scaffold is KGN.

Other records listing Helios Biomedical, Inc. as applicant

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.

K250420Helios Dura Regeneration Matrix

Related Devices (Code: KGN)

K260596Collagen Wound PowderVentris Medical K260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

Official Source

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