510(k) K253662
K253662 is an FDA 510(k) premarket notification submitted by Luwi, LLC for the device "LIXI (LXOSFM1)". The FDA issued a decision of Substantially Equivalent on July 14, 2026. The device falls under product code MSC (Barrier, Std, Oral Sex), a Class II device regulated under 21 CFR 884.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2026
- Date Received
- November 20, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Barrier, Std, Oral Sex
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type