Clearance Summary
Ion-L received FDA 510(k) clearance under submission number K261209, sponsored by SurGenTec, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2026-06-11.
- Submission: K261209
- Applicant / Sponsor: SurGenTec, LLC
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2026-06-11
Classification & Regulation
This clearance is catalogued under FDA product code MRW , within the Unknown review panel as a device.