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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Laser, Scanning
510(k) Number K134039
Device Name DAYTONA ICG (P200TICG)
Applicant
Optos Plc.
555 13th St., NW
Washington,  DC  20004
Applicant Contact RANDY PREBULA
Correspondent
Optos Plc.
555 13th St., NW
Washington,  DC  20004
Correspondent Contact RANDY PREBULA
Regulation Number886.1570
Classification Product Code
MYC  
Date Received12/31/2013
Decision Date 04/11/2014
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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