HARU Orgasm by jack herer water based lubricant (WL-OJ) +2 more— 510(k) K253989

Name: FDA 510(k) clearance K253989
Creator: U.S. Food and Drug Administration
Published: 2026-09-03

Substantially Equivalent

Maxigen Biotech, Inc.

FDA 510(k) clearance K253989 for HARU Orgasm by jack herer water based lubricant (WL-OJ) +2 more, Substantially Equivalent on 2026-09-03. Applicant: Maxigen Biotech, Inc.. Device class: 2.

Clearance details

Device name as filed: HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)
Applicant: Maxigen Biotech, Inc.
Product code: Code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2025-12-12
Decision date: 2026-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan, TW

Download summary PDF View on FDA.gov ↗

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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.