Cleared Traditional

K210972 - H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two
(FDA 510(k) Clearance)

K210972 · CC Wellness, LLC · Obstetrics & Gynecology

Jun 2021

Decision

71d

Days

Class 2

Risk

K210972 is an FDA 510(k) clearance for the H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two. 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 June 10, 2021, 71 days after receiving the submission on March 31, 2021.

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	K210972 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2021
Decision Date	June 10, 2021
Days to Decision	71 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.