510(k) K253115
K253115 is an FDA 510(k) premarket notification submitted by Movmedix S.A.S. for the device "LARS ACJ". The FDA issued a decision of Substantially Equivalent on June 10, 2026. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2026
- Date Received
- September 24, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Bolt Nut
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type