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510(k) K101325

STELLARIS PC VISION ENHANCEMENT SYSTEM by Bausch & Lomb, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2010
Date Received
May 12, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

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