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 IDK180508
510k NumberK180508
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 Received2018-02-26
Decision Date2018-05-18
Summary:summary

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