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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 K101817
Device Name LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N
Applicant
Fotona D.D.
Stegne 7
Ljubljana,  SI 1210
Applicant Contact STOJAN TROST
Correspondent
Fotona D.D.
Stegne 7
Ljubljana,  SI 1210
Correspondent Contact STOJAN TROST
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/30/2010
Decision Date 11/22/2010
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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