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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K252845
Device Name Venus Nova (FP-2001)
Applicant
Venus Concept, Inc.
1800 Bering Dr.
San Jose,  CA  95112
Applicant Contact Danielle Fulk
Correspondent
Venus Concept, Inc.
1800 Bering Dr.
San Jose,  CA  95112
Correspondent Contact Danielle Fulk
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
NGX   PBX  
Date Received09/08/2025
Decision Date 11/06/2025
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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