Powered Laser Surgical Instrument

RAJA Trading Company, Inc.

The following data is part of a premarket notification filed by Raja Trading Company, Inc. with the FDA for Oxylight.

Pre-market Notification Details

Device IDK200104
510k NumberK200104
Device Name:Oxylight
ClassificationPowered Laser Surgical Instrument
Applicant RAJA Trading Company, Inc. 801 South Olive Avenue, Suite 124 West Palm Beach,  FL  33401
ContactRobert J Adipietro
CorrespondentYolanda Smith
Smith Associates 1468 Harwell Ave Crofton,  MD  21114
Product CodeGEX  
Subsequent Product CodeISA
Subsequent Product CodeNFO
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-17
Decision Date2020-06-04

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