Clearance Summary
OTE MPS 045 Multi-purpose Lens Care Solution received FDA 510(k) clearance under submission number K210051, sponsored by Ote North America, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2021-05-26.
- Submission: K210051
- Applicant / Sponsor: Ote North America, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 2021-05-26
Classification & Regulation
This clearance is catalogued under FDA product code LPN and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.