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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 K201738
Device Name SubNovii Advanced Plasma Technology
Applicant
Cartessa Aesthetics
175 Broadhollow Rd.
Melville,  NY  11747
Applicant Contact Gabe Lubin
Correspondent
Hoy and Associates
3916 N. Potsdam Ave.
Souix Falls,  SD  57104
Correspondent Contact Connie Hoy
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/25/2020
Decision Date 09/10/2020
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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