Cleared Traditional

K212705 - Actively Trying Personal Lubricant Unfragrance (FDA 510(k) Clearance)

K212705 · CC Wellness, LLC · Obstetrics & Gynecology device
Feb 2022
Decision
167d
Days
Class 2
Risk

K212705 is an FDA 510(k) clearance for the Actively Trying Personal Lubricant Unfragrance. This device is classified as a Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible (Class II - Special Controls, product code PEB).

Submitted by CC Wellness, LLC (Valencia, US). The FDA issued a Cleared decision on February 9, 2022, 167 days after receiving the submission on August 26, 2021.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300. A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Sexual Activity And Supplement The Body's Natural Lubrication. This Device May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms. This Device Is Compatible With Sperm, Oocytes, And Embryos And Can Be Used By Couples Trying To Conceive. This Device May Also Be Used During Fertility Interventions To Facilitate Entry Of Diagnostic And Therapeutic Devices..

Submission Details

510(k) Number K212705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2021
Decision Date February 09, 2022
Days to Decision 167 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code PEB - Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Device Class Class II - Special Controls
CFR Regulation 21 CFR 884.5300
Definition A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Sexual Activity And Supplement The Body's Natural Lubrication. This Device May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms. This Device Is Compatible With Sperm, Oocytes, And Embryos And Can Be Used By Couples Trying To Conceive. This Device May Also Be Used During Fertility Interventions To Facilitate Entry Of Diagnostic And Therapeutic Devices.