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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
510(k) Number K080513
Device Name QLASER SYSTEM
Applicant
2035, INC.
13 RED FOX LANE
littleton,  CO  80127
Applicant Contact kevin walls
Correspondent
2035, INC.
13 RED FOX LANE
littleton,  CO  80127
Correspondent Contact kevin walls
Regulation Number890.5500
Classification Product Code
NHN  
Date Received02/25/2008
Decision Date 01/30/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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