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510(k) K240169

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) by Bausch and Lomb, Incorporated — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2024
Date Received
January 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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