Pilot Ultra 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 Ultra Diode Laser.

Pre-market Notification Details

Device IDK142226
510k NumberK142226
Device Name:Pilot Ultra 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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