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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 K020374
Device Name OCULIGHT SL/SLX
Applicant
IRIDEX CORP.
1212 TERRA BELLA AVE.
MOUNTAIN VIEW,  CA  94043
Applicant Contact JOHN D'ANGELO
Correspondent
IRIDEX CORP.
1212 TERRA BELLA AVE.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact JOHN D'ANGELO
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received02/04/2002
Decision Date 05/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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