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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 K992298
Device Name IRIDERM, MODEL APEX 800
Applicant
Iridex Corp
1212 Terra Bella Ave.
Mountain View,  CA  94043
Applicant Contact BRAD RENTON
Correspondent
Iridex Corp
1212 Terra Bella Ave.
Mountain View,  CA  94043
Correspondent Contact BRAD RENTON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/08/1999
Decision Date 12/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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