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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Manual
510(k) Number K153694
Device Name Icare ic100
Applicant
Icare Finland OY
Ayritie 22
Vantaa,  FI FI-01510
Applicant Contact Matti Tulikoura
Correspondent
Icare Finland OY
Ayritie 22
Vantaa,  FI FI-01510
Correspondent Contact Matti Tulikoura
Regulation Number886.1930
Classification Product Code
HKY  
Subsequent Product Code
HKX  
Date Received12/23/2015
Decision Date 04/19/2016
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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