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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
510(k) Number K885163
Device Name DIOPTICS EYESHIELDS
Applicant
Dioptics
15550 Rockfield Blvd., Suite C
Irvine,  CA  92714
Applicant Contact ELEANOR LANGLEY
Correspondent
Dioptics
15550 Rockfield Blvd., Suite C
Irvine,  CA  92714
Correspondent Contact ELEANOR LANGLEY
Regulation Number886.4750
Classification Product Code
HOY  
Date Received12/13/1988
Decision Date 12/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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