Classys, Inc. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Classys, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CuRAS hybrid, Volnewmer™, SCIZER (SC1-M410)
3
Total
3
Cleared
0
Denied
Classys, Inc. has 3 FDA 510(k) cleared medical devices. Based in Seoul, KR.
Latest FDA clearance: Nov 2025. Active since 2023. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Classys, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Elexes Medical Consulting, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Classys, Inc.
3 devices