DeviceClearance

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

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.

Summary

Maxigen Biotech's clearance covers three water-based personal lubricants under the HARU name: Orgasm by jack herer (WL-OJ), Orgasm (WL-OR), and STEAMY (WL-ST). Product code NUC is personal lubricants. The record doesn't give formulations.

Class II, 21 CFR 884.5300. Obstetrics/Gynecology is both the classification panel and the review panel, and the submission was a Traditional 510(k).

Maxigen filed from Taoyuan, Taiwan. Review took 265 calendar days (December 12, 2025 to September 3, 2026).

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
Product code NUC
Device class
Class 2
Regulation
21 CFR 884.5300
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Taoyuan, TW
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NUC

product code NUC
Other
8
Total
8

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

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