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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 K063427
Device Name LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM
Applicant
Lynton Lasers Limited
Lynton House, Manor Ln.
Holmes Chapel, Cheshire,  GB CW4 8AF
Applicant Contact ANDREW JOHN BERRY
Correspondent
Lynton Lasers Limited
Lynton House, Manor Ln.
Holmes Chapel, Cheshire,  GB CW4 8AF
Correspondent Contact ANDREW JOHN BERRY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/13/2006
Decision Date 07/25/2007
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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