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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Std, Oral Sex
510(k) Number K253662
Device Name LIXI (LXOSFM1)
Applicant
Luwi, LLC
148 Randhurst Village Dr.
Mount Prospect,  IL  60056
Applicant Contact Lisa Kinsella
Correspondent
Rook Quality Systems
1155 Mount Vernon Hwy., Suite 800
Dunwoody,  GA  30338
Correspondent Contact Tyler Ting
Regulation Number884.5300
Classification Product Code
MSC  
Date Received11/20/2025
Decision Date 07/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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