510(k) K212705

Actively Trying Personal Lubricant Unfragrance by CC Wellness, LLC — Product Code PEB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 9, 2022
Date Received: August 26, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Device Class: Class II
Regulation Number: 884.5300
Review Panel: OB
Submission Type

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.

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Other clearances for product code PEB

K212885 — Actively Trying Personal Lubricant Rose Scented (February 11, 2022)
K193450 — Pre-Seed Fertility Lubricant (July 23, 2020)
K190872 — BioGenesis Fertility Lubricant (November 7, 2019)
K182585 — JO Actively Trying Personal Lubricant (April 26, 2019)
K162319 — BabyDance Fertility Lubricant (April 28, 2017)
K141132 — ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT (January 9, 2015)
K131355 — CONCEIVE PLUS (November 7, 2013)
K072741 — PRE-VA VAGINAL LUBRICANT (July 16, 2008)
K051436 — PRE' VAGINAL LUBRICANT (October 13, 2006)