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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 K180993
Device Name Beacon Advanced CO2 Laser System
Applicant
Omniguide, Inc.
4 Maguire Rd.
Lexington,  MA  02421
Applicant Contact Sam Wade
Correspondent
Omniguide, Inc.
4 Maguire Rd.
Lexington,  MA  02421
Correspondent Contact Sam Wade
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/16/2018
Decision Date 06/28/2018
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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