Sterling Supreme 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 Sterling Supreme Diode Laser.

Pre-market Notification Details

Device IDK171986
510k NumberK171986
Device Name:Sterling Supreme 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 Received2017-07-03
Decision Date2017-09-22
Summary:summary

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