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 a medical device manufactured by Helios Biomedical, Inc.. It received FDA 510(k) clearance on 2025-08-15 under approval 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. It is manufactured by Helios Biomedical, Inc.. The 510(k) number is K250397.

When was Helios Dermal Scaffold approved by the FDA?

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

What company makes Helios Dermal Scaffold?

Helios Dermal Scaffold is manufactured by Helios Biomedical, Inc..

What is the FDA product code for Helios Dermal Scaffold?

The FDA product code for Helios Dermal Scaffold is KGN.

Related Clinical Trials

NCT05945329 Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation RECRUITING

Other Devices by Helios Biomedical, Inc.

K250420Helios Dura Regeneration Matrix

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

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.