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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 K181662
Device Name Iridex TruFocus LIO Premiere
Applicant
Iridex Corporation
1212 Terra Bella Ave.
Mountain View,  CA  94043
Applicant Contact Edward J. Sinclair
Correspondent
Iridex Corporation
1212 Terra Bella Ave.
Mountain View,  CA  94043
Correspondent Contact Edward J. Sinclair
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/25/2018
Decision Date 09/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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