Play and Joy Water-Based Lubricant— 510(k) K221137

Name: FDA 510(k) clearance K221137
Creator: U.S. Food and Drug Administration
Published: 2023-07-11

Substantially Equivalent

Innovemed Bio-Tech Co., Ltd.

FDA 510(k) clearance K221137 for Play and Joy Water-Based Lubricant, Substantially Equivalent on 2023-07-11. Applicant: Innovemed Bio-Tech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Innovemed Bio-Tech Co., Ltd.
Product code: Code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2022-04-19
Decision date: 2023-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, 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

More clearances from Innovemed Bio-Tech Co., Ltd.

view all

K220646 — Play&Joy InvisiLube Lubricant Capsule2023-07-10

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.