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510(k) K023676

APPLANATION TONOMETER by Optilasa, S.L. — Product Code HKX

K023676 is an FDA 510(k) premarket notification submitted by Optilasa, S.L. for the device "APPLANATION TONOMETER". The FDA issued a decision of Substantially Equivalent on April 24, 2003. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2003
Date Received
November 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

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FDA data resources