K150841 is an FDA 510(k) clearance for the Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal 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 December 29, 2015, 274 days after receiving the submission on March 30, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K150841 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 30, 2015 |
| Decision Date | December 29, 2015 |
| Days to Decision | 274 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. |