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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 K141555
Device Name ADVANTAGE
Applicant
Lutronic Corporation
6 Neshaminy Interplex, Suite 100
Trevose,  PA  19053
Applicant Contact JHUNG W VOJIR
Correspondent
Lutronic Corporation
6 Neshaminy Interplex, Suite 100
Trevose,  PA  19053
Correspondent Contact JHUNG W VOJIR
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/12/2014
Decision Date 11/06/2014
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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