K251011 is an FDA 510(k) clearance for the Chiavaye Personal Moisturizer. This device is classified as a Lubricant, Personal (Class II - Special Controls, product code NUC).
Submitted by Unipack, LLC (South Plainfield, US). The FDA issued a Cleared decision on December 19, 2025, 262 days after receiving the submission on April 1, 2025.
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 | K251011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2025 |
| Decision Date | December 19, 2025 |
| Days to Decision | 262 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. |