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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K250397
Device Name Helios Dermal Scaffold
Applicant
Helios Biomedical, Inc.
11 Dellbrook Rd.
Weston,  MA  02493
Applicant Contact Yiannis Monovoukas
Correspondent
QUARAS, LLC
2101 Camino Rey
Fullerton,  CA  92833
Correspondent Contact Roshana Ahmed
Classification Product Code
KGN  
Date Received02/12/2025
Decision Date 08/15/2025
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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