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510(k) K252175

LANDR Contact LENS Case by Fourth Axis, LLC — Product Code LRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2026
Date Received
July 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Case, Contact Lens
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

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