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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
Model ZENO 2, ZENO4
Device Name MIRA LASERS
Applicant
MIRA LASERS LLC
p.o. box 237-023
shanghai, 
Contact diana hong
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/27/2012
Decision Date 01/15/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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