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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 K202988
Device Name Tixel System
Applicant
Novoxel , Ltd.
43 Hamelaha St.
Netanya,  IL 4250573
Applicant Contact Ronen Shavit
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/30/2020
Decision Date 02/25/2021
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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