Cleared Traditional

K230674 - JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114
(FDA 510(k) Clearance)

K230674 · CC Wellness, LLC · Obstetrics & Gynecology

May 2023

Decision

59d

Days

Class 2

Risk

K230674 is an FDA 510(k) clearance for the JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114, a Lubricant, Personal (Class II — Special Controls, product code NUC), submitted by CC Wellness, LLC (Valencia, US). The FDA issued a Cleared decision on May 8, 2023, 59 days after receiving the submission on March 10, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K230674 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2023
Decision Date	May 08, 2023
Days to Decision	59 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.