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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 K103455
Device Name SPECTRA LASER SYSTEM
Applicant
Lutronic Corporation
51 Everett Dr.,
Unit A-50
Princeton Junction,  NJ  08550
Applicant Contact JHUNG WON VOJIR
Correspondent
Lutronic Corporation
51 Everett Dr.,
Unit A-50
Princeton Junction,  NJ  08550
Correspondent Contact JHUNG WON VOJIR
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/23/2010
Decision Date 04/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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