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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K202175
Device Name OxyLight 2.0
Applicant
Raja Trading Company, Inc.
2801 Juniper St., Suite 2
Fairfax,  VA  22031
Applicant Contact Christine K. Powers
Correspondent
Smith Associates
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact Yolanda R. Smith
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
GFE   IPF  
Date Received08/04/2020
Decision Date 12/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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