Clearance Summary
NAVILAS LASER SYSTEM received FDA 510(k) clearance under submission number K091064, 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 2009-10-27.
- Submission: K091064
- Applicant / Sponsor: Od-Os GmbH
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2009-10-27
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.