Clearance Summary
Navilas Laser System 577sl (156691) received FDA 510(k) clearance under submission number K251772, sponsored by Od-Os GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2025-10-29.
- Submission: K251772
- Applicant / Sponsor: Od-Os GmbH
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2025-10-29
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.