PIONEER 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 Pioneer Elite Diode Laser.

Pre-market Notification Details

Device IDK131059
510k NumberK131059
Device Name:PIONEER 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-16
Decision Date2013-09-13
Summary:summary

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