K254101
- 510(k) number
- K254101
- Device name
- Julva Velvé Water-Based Personal Lubricant
- Applicant
- Golden Isles Medical, Inc. GA · US
- Product code
- NUC — Lubricant, Personal
- Decision date
- 2026-04-16
- Date received
- 2025-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K254101.pdf
Official FDA record: K254101
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.