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510(k) K223700

BOSS™ by Intelon Optics, Inc. — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2024
Date Received
December 12, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Analysis, Anterior Segment
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

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