Water Solubility Human Body Lubricant— 510(k) K243107

Name: FDA 510(k) clearance K243107
Creator: U.S. Food and Drug Administration
Published: 2025-05-09

Substantially Equivalent

Dongguan Yanxuan Biotechnology Co., Ltd.

FDA 510(k) clearance K243107 for Water Solubility Human Body Lubricant, Substantially Equivalent on 2025-05-09. Applicant: Dongguan Yanxuan Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dongguan Yanxuan Biotechnology Co., Ltd.
Product code: Code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2024-09-30
Decision date: 2025-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguang, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code NUC

view all

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
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.