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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 K082586
Device Name LIGHTWAVE PROFESSIONAL DELUXE
Original Applicant
LIGHTWAVE TECHNOLOGIES LLC
55 northern blvd
suite 200
great neck,  NY  11021
Original Contact maria f griffin
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/08/2008
Decision Date 01/04/2010
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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