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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
510(k) Number K150138
Device Name Aspen Laser Systems Therapy Laser System
Applicant
Aspen Laser Systems, LLC
316 California Ave., Suite 788
Reno,  NV  89509
Applicant Contact PAUL SCHWEN
Correspondent
Aspen Laser Systems, LLC
970 S. Dawson Way #14
Aurora,  CO  80012
Correspondent Contact A. BRAUN HENDERSON
Regulation Number878.4810
Classification Product Code
PDZ  
Date Received01/22/2015
Decision Date 05/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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