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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 K121286
Device Name EPIC 10
Original Applicant
4 cromwell
irvine,  CA  92618 1816
Original Contact robert yang
Regulation Number878.4810
Classification Product Code
Subsequent Product Code
Date Received05/09/2012
Decision Date 09/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No