Clearance Summary
CONFOCAL MICROSCOPE received FDA 510(k) clearance under submission number K970414, sponsored by Con-S , 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 1997-07-15.
- Submission: K970414
- Applicant / Sponsor: Con-S , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 1997-07-15
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.