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510(k) K201922

Trophikos Vaginal Moisturizer by Trophikos, LLC — Product Code NUC

K201922 is an FDA 510(k) premarket notification submitted by Trophikos, LLC for the device "Trophikos Vaginal Moisturizer". The FDA issued a decision of Substantially Equivalent on Jan 14, 2021. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 14, 2021
Date Received
Jul 10, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type
510(k)

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

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FDA data resources