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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 K243147
Device Name LGO-Surgical Laser Fibers
Applicant
Light Guide Optics International , Ltd.
Celtniecibas St. 8
Livani,  LV LV-5316
Applicant Contact Santa Vucina
Correspondent
Light Guide Optics International , Ltd.
Celtniecibas St. 8
Livani,  LV LV-5316
Correspondent Contact Santa Vucina
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/30/2024
Decision Date 12/21/2024
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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