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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
FOIA Releasable 510(k) K082586
Device Name LIGHTWAVE PROFESSIONAL DELUXE
Applicant
LIGHTWAVE TECHNOLOGIES LLC
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Applicant Contact MARIA F GRIFFIN
Correspondent
LIGHTWAVE TECHNOLOGIES LLC
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Correspondent Contact MARIA F GRIFFIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/08/2008
Decision Date 01/04/2010
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
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