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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 K121475
Device Name TXCELL SCANNING LASER DELIVERY SYSTEM
Original Applicant
IRIDEX CORP.
1212 terra bella ave
mountain view,  CA  94043
Original Contact paul h hardiman
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/18/2012
Decision Date 11/28/2012
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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