FDA 510(k) Application Details - K063574

Device Classification Name Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

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510(K) Number K063574
Device Name Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Applicant MEDICAL LASER SYSTEMS INC
800 CONNECTICUT AVE. NW
SUITE 500
WAHINGTON, DC 20006 US
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Contact MIKI KOLTON
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Regulation Number 890.5500

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Classification Product Code NHN
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Date Received 11/29/2006
Decision Date 01/29/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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