Julva Velvé Water-Based Personal Lubricant— 510(k) K254101

Name: FDA 510(k) clearance K254101
Creator: U.S. Food and Drug Administration
Published: 2026-04-16

Substantially Equivalent

Golden Isles Medical, Inc.

FDA 510(k) clearance K254101 for Julva Velvé Water-Based Personal Lubricant, Substantially Equivalent on 2026-04-16. Applicant: Golden Isles Medical, Inc.. Device class: 2.

Summary

Golden Isles Medical's Julva Velvé Water-Based Personal Lubricant is filed under product code NUC (Lubricant, Personal).

Class II, 21 CFR 884.5300. It came in as a Traditional 510(k), and Obstetrics/Gynecology is both the classification panel and the review panel.

Golden Isles Medical filed from Brunswick, Georgia. Review took 118 calendar days (December 19, 2025 to April 16, 2026).

Clearance details

Applicant: Golden Isles Medical, Inc.
Product code: Product code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2025-12-19
Decision date: 2026-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brunswick, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NUC

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K260117 — Everslide2026-09-23
K253989 — HARU Orgasm by jack herer water based lubricant (WL-OJ) +2 more2026-09-03
K261905 — BUM Oil2026-08-07
K261177 — PINKSLIP Water-Based Personal Lubricant and Moisturizer2026-07-09
K261909 — Plum Vagiceuticals Vaginal Moisturizing Suppositories2026-07-06

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.