Cleared Traditional

K232090 - JO Coconut Hybrid Warming Personal Lubricant
(FDA 510(k) Clearance)

K232090 · CC Wellness, LLC · Obstetrics & Gynecology

Oct 2023

Decision

90d

Days

Class 2

Risk

K232090 is an FDA 510(k) clearance for the JO Coconut Hybrid Warming Personal Lubricant. This device is classified as a Lubricant, Personal (Class II — Special Controls, product code NUC).

Submitted by CC Wellness, LLC (Valencia, US). The FDA issued a Cleared decision on October 11, 2023, 90 days after receiving the submission on July 13, 2023.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300. 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..

Submission Details

510(k) Number	K232090 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2023
Decision Date	October 11, 2023
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	NUC — Lubricant, Personal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5300
Definition	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.