SubNovii Advanced Plasma Technology

Electrosurgical, Cutting & Coagulation & Accessories

Cartessa Aesthetics

The following data is part of a premarket notification filed by Cartessa Aesthetics with the FDA for Subnovii Advanced Plasma Technology.

Pre-market Notification Details

Device IDK201738
510k NumberK201738
Device Name:SubNovii Advanced Plasma Technology
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Cartessa Aesthetics 175 Broadhollow Rd Melville,  NY  11747
ContactGabe Lubin
CorrespondentConnie Hoy
Hoy And Associates 3916 North Potsdam Ave Souix Falls,  SD  57104
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-25
Decision Date2020-09-10

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