Clearance Summary
KOWA, FM-600, MODEL LSS50 received FDA 510(k) clearance under submission number K091039, 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 2009-08-07.
- Submission: K091039
- Applicant / Sponsor: Kowa Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2009-08-07
Classification & Regulation
This clearance is catalogued under FDA product code MYC and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.