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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K243421
Device Name Lelo Hex Lubricated Natural Rubber Latex Condom
Applicant
Lelo, Inc.
5799 Fontanoso Way
San Jose,  CA  95138
Applicant Contact Pavle Sedic
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/04/2024
Decision Date 03/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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