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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K242958
Device Name Joylux Intimacy Gel (PG3100)
Applicant
Joylux, Inc.
120 Lakeside Ave.
Seattle,  WA  98122
Applicant Contact Colette Courtion
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/25/2024
Decision Date 03/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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