Pilot Elite Diode Laser

Powered Laser Surgical Instrument

CAO Group, Inc.

The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Pilot Elite Diode Laser.

Pre-market Notification Details

Device IDK142225
510k NumberK142225
Device Name:Pilot Elite Diode Laser
ClassificationPowered Laser Surgical Instrument
Applicant CAO Group, Inc. 4628 West Skyhawk Drive West Jordan,  UT  84084
ContactRobert K Larsen
CorrespondentRobert K Larsen
CAO Group, Inc. 4628 West Skyhawk Drive West Jordan,  UT  84084
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-13
Decision Date2014-09-12
Summary:summary

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