LIXI (LXOSFM1)— 510(k) K253662
Substantially EquivalentLuwi, LLC
FDA 510(k) clearance K253662 for LIXI (LXOSFM1), Substantially Equivalent on 2026-07-14. Applicant: Luwi, LLC. Device class: 2.
Summary
Luwi's LIXI (LXOSFM1) is filed under MSC, oral sex STD barriers. The record gives the model as LXOSFM1 but no materials or dimensions.
Class II, 21 CFR 884.5300. Obstetrics and Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Luwi filed from Mount Prospect, Illinois. Review took 236 calendar days (November 20, 2025 to July 14, 2026).
Clearance details
- Applicant
- Luwi, LLC
- Product code
- Product code MSC
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mount Prospect, IL, US
Recent devices under product code MSC
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