510(k) K250397

Helios Dermal Scaffold by Helios Biomedical, Inc. — Product Code KGN

K250397 is an FDA 510(k) premarket notification submitted by Helios Biomedical, Inc. for the device "Helios Dermal Scaffold". The FDA issued a decision of Substantially Equivalent on August 15, 2025. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Helios Biomedical, Inc. has at least 1 other 510(k) clearance on record.