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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 K250688
Device Name Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)
Applicant
Acotec Scientific Co., Ltd.
3rd, 4th And 5th Floor, Bldg. #8,
16 Hongdabei Rd., Bda
Beijing,  CN 100176
Applicant Contact Anna Chan
Correspondent
Fabrica Consulting, LLC
73 Lincoln Dr.
Sausalito,  CA  94965
Correspondent Contact Sara Toyloy
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/06/2025
Decision Date 10/07/2025
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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