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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 K143154
Device Name IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)
Applicant
Iridex Corporation
1212 Terra Bella Ave.
Mountain View,  CA  94043
Applicant Contact PAUL H HARDIMAN
Correspondent
Kathy Maynor
26 Rebecca St.
Homosassa,  FL  34446
Correspondent Contact KATHY MAYNOR
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/03/2014
Decision Date 01/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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