Clearance Summary
KOWA GENESIS-D HAND-HELD RETINAL CAMERA received FDA 510(k) clearance under submission number K050271, 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 2005-11-03.
- Submission: K050271
- Applicant / Sponsor: Kowa Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1120
- Decision date: 2005-11-03
Classification & Regulation
This clearance is catalogued under FDA product code HKI and 21 CFR 886.1120, within the Ophthalmic review panel as a Class II device.