FDA 510(k) Application Details - K150138

Device Classification Name

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510(K) Number K150138
Device Name Aspen Laser Systems Therapy Laser System
Applicant ASPEN LASER SYSTEMS, LLC
316 CALIFORNIA AVENUE, SUITE 788
RENO, NV 89509 US
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Contact PAUL SCHWEN
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Regulation Number

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Classification Product Code PDZ
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Date Received 01/22/2015
Decision Date 05/08/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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