510(k) clearance
HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)
- 510(k) number
- K253989
- Applicant
- Maxigen Biotech, Inc.
- Decision date
- Sep 3, 2026
- Date received
- Dec 12, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NUC
- Device type
- Lubricant, Personal
- Device class
- Class II
- Regulation
- 21 CFR 884.5300
- Advisory committee
- Obstetrics/Gynecology
- Statement or summary
- Summary
- Third party
- N
- Location
- Taoyuan, TW