Joy Drops (TM) Natural Personal Lubricant Gel

FDA 510(k) K140506 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa

Substantially Equivalent

510(k) numberK140506

Submission

Device name
Joy Drops (TM) Natural Personal Lubricant Gel
Applicant
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
San Francisco, CA, US
Received
February 27, 2014
Decision date
April 17, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUC – Lubricant, Personal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5300
Specialty
Obstetrics/Gynecology

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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Questions and answers

When was Joy Drops (TM) Natural Personal Lubricant Gel cleared by the FDA?

Joy Drops (TM) Natural Personal Lubricant Gel (K140506) received a 510(k) decision of Substantially Equivalent on April 17, 2015, 414 days after the submission was received.

What is the product code of K140506?

The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.