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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Ac-Powered
510(k) Number K023676
Device Name APPLANATION TONOMETER
Applicant
Optilasa, S.L.
338 Arturo Soria St.
Madrid,  ES 28033
Applicant Contact JOSE M BOBES
Correspondent
Optilasa, S.L.
338 Arturo Soria St.
Madrid,  ES 28033
Correspondent Contact JOSE M BOBES
Regulation Number886.1930
Classification Product Code
HKX  
Date Received11/01/2002
Decision Date 04/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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