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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K252175
Device Name LANDR Contact LENS Case
Applicant
Fourth Axis, LLC
8139 S Eyele Ave.
Boise,  ID  83716
Applicant Contact Christine Brown
Correspondent
Bdra Consulting, LLC
1 Clearewater Ct.
Damascus,  MD  20872
Correspondent Contact Srinagesh Koushik
Regulation Number886.5928
Classification Product Code
LRX  
Date Received07/11/2025
Decision Date 02/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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