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510(k) K043503

VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 by Visx, Incorporated — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2005
Date Received
December 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Other clearances by Visx, Incorporated

  • K000327 — WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 (May 2, 2000)

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