Cleared Traditional

LUVENA VAGINAL MOISTURIZER & LUBRICANT

K162235 · Laclede, Inc. · Obstetrics & Gynecology

Mar 2017

Decision

227d

Days

Class 2

Risk

About This 510(k) Submission

K162235 is an FDA 510(k) clearance for the LUVENA VAGINAL MOISTURIZER & LUBRICANT, a Lubricant, Personal (Class II — Special Controls, product code NUC), submitted by Laclede, Inc. (Rancho Dominguez, US). The FDA issued a Cleared decision on March 24, 2017, 227 days after receiving the submission on August 9, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K162235 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2016
Decision Date	March 24, 2017
Days to Decision	227 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.