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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K230228
Device Name Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
Applicant
Iridex Corporation
1212 Terra Bella Ave.
Mountain View,  CA  94043
Applicant Contact Mari Iwamoto
Correspondent
Iridex Corporation
1212 Terra Bella Ave.
Mountain View,  CA  94043
Correspondent Contact Mari Iwamoto
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received01/27/2023
Decision Date 02/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
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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