K222567 is an FDA 510(k) clearance for the Playground For All Love Sesh. This device is classified as a Lubricant, Personal (Class II - Special Controls, product code NUC).
Submitted by Playground For All (San Francisco, US). The FDA issued a Cleared decision on January 30, 2023, 159 days after receiving the submission on August 24, 2022.
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..
| 510(k) Number | K222567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2022 |
| Decision Date | January 30, 2023 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| 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. |