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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 K213592
Device Name Iridex 810 Laser
Applicant
Iridex Corporation
1212 Terra Bella Ave.
Mountain View,  CA  94043
Applicant Contact Bill Hyatt
Correspondent
Iridex Corporation
1212 Terra Bella Ave.
Mountain View,  CA  94043
Correspondent Contact Bill Hyatt
Regulation Number886.4390
Classification Product Code
HQF  
Date Received11/12/2021
Decision Date 03/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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