Clearance Summary
Leos Laser and Endoscopy System received FDA 510(k) clearance under submission number K240615, sponsored by Beaver-Visitec International, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2025-04-03.
- Submission: K240615
- Applicant / Sponsor: Beaver-Visitec International, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2025-04-03
Classification & Regulation
This clearance is catalogued under FDA product code HQF and 21 CFR 886.4390, within the Ophthalmic review panel as a Class II device.