Clearance Summary
KOWA KT-800 received FDA 510(k) clearance under submission number K053444, sponsored by Kowa Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2006-06-09.
- Submission: K053444
- Applicant / Sponsor: Kowa Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 2006-06-09
Classification & Regulation
This clearance is catalogued under FDA product code HKX and 21 CFR 886.1930, within the Ophthalmic review panel as a Class II device.