JOULE SYSTEM

Powered Laser Surgical Instrument

Sciton, Inc

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

Pre-market Notification Details

Device IDK173285
510k NumberK173285
Device Name:JOULE SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant Sciton, Inc 925 Commercial Street Palo Alto,  CA  94303
ContactJay M. Patel
CorrespondentJay M. 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 Received2017-10-16
Decision Date2018-01-29
Summary:summary

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