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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K233602
Device Name P200TE (A10700)
Applicant
Optos Plc.
Queensferry House
Carnegie Campus, Enterprise Way
Dunfermline,  GB KY11 8GR
Applicant Contact Graham McLeod
Correspondent
Optos Plc.
Queensferry House
Carnegie Campus, Enterprise Way
Dunfermline,  GB KY11 8GR
Correspondent Contact Graham McLeod
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Code
MYC  
Date Received11/09/2023
Decision Date 05/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT05844852
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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