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.

Clearance details

Applicant: Golden Isles Medical, Inc.
Product code: 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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K261905 — BUM Oil2026-08-07
K261177 — PINKSLIP Water-Based Personal Lubricant and Moisturizer2026-07-09
K261909 — Plum Vagiceuticals Vaginal Moisturizing Suppositories2026-07-06
K254011 — Flow Water-Based Personal Lubricant2026-06-22

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.