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510(k) K232084

Stellaris Elite vision enhancement system by Bausch and Lomb — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2024
Date Received
July 13, 2023
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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