K212705 is an FDA 510(k) clearance for the Actively Trying Personal Lubricant Unfragrance, 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 review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K212705 FDA.gov |
| FDA Decision | Cleared 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 |
| 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. |