Clearance Summary
LASER FLARE CELL METER FC-1000 received FDA 510(k) clearance under submission number K880920, sponsored by Kowa Optimed, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1988-09-27.
- Submission: K880920
- Applicant / Sponsor: Kowa Optimed, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 1988-09-27
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.