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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K253123
Device Name CuRAS hybrid
Applicant
Classys, Inc.
208, Teheran-Ro, Gangnam-Gu
Seoul,  KR 06220
Applicant Contact Judy Seung-yeon Cho
Correspondent
Classys, Inc.
208, Teheran-Ro, Gangnam-Gu
Seoul,  KR 06220
Correspondent Contact Judy Seung-yeon Cho
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/25/2025
Decision Date 11/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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