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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K123004
Device Name MIRA LASERS
Applicant
Mira Lasers, LLC
P.O. Box 237-023
Shanghai,  CN 200237
Applicant Contact Diana Hong
Correspondent
Mira Lasers, LLC
P.O. Box 237-023
Shanghai,  CN 200237
Correspondent Contact Diana Hong
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/27/2012
Decision Date 01/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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