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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 K223132
Device Name Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
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 Received10/03/2022
Decision Date 11/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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