Clearance Summary
KOWA SL-15 received FDA 510(k) clearance under submission number K063640, sponsored by Kowa Co. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2006-12-18.
- Submission: K063640
- Applicant / Sponsor: Kowa Co. , Ltd.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2006-12-18
Classification & Regulation
This clearance is catalogued under FDA product code HJO and 21 CFR 886.1850, within the Ophthalmic review panel as a Class II device.