FDA cleared the HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) from Maxigen Biotech, Inc. on Sep 3, 2026 under K253989, a traditional 510(k). The device falls under product code NUC, Lubricant, Personal, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.
FDA logged the submission as received on Dec 12, 2025. The decision came 265 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Maxigen Biotech, Inc. in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K253989?
K253989 is the FDA 510(k) for HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST), submitted by Maxigen Biotech, Inc.. FDA's decision date was Sep 3, 2026, under product code NUC (Lubricant, Personal).
Who makes the HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)?
Maxigen Biotech, Inc., based in Taoyuan, is the applicant of record for K253989.
How long did the K253989 review take?
FDA received the submission on Dec 12, 2025 and issued its decision on Sep 3, 2026, 265 days later.