MJOULE System And Accessories

Powered Laser Surgical Instrument

Sciton, Inc

The following data is part of a premarket notification filed by Sciton, Inc with the FDA for Mjoule System And Accessories.

Pre-market Notification Details

Device IDK213350
510k NumberK213350
Device Name:MJOULE System And Accessories
ClassificationPowered Laser Surgical Instrument
Applicant Sciton, Inc 925 Commercial Street Palo Alto,  CA  94303
ContactJay Patel
CorrespondentJay Patel
Sciton, Inc 925 Commercial Street Palo Alto,  CA  94303
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-08
Decision Date2022-04-15

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