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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K072048
Device Name LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE
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 Number890.5500
Classification Product Code
ILY  
Date Received07/25/2007
Decision Date 11/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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