Clearance Summary
OPTYSE OPHTHALMOSCOPE received FDA 510(k) clearance under submission number K061278, sponsored by Ophthalmos , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2006-05-16.
- Submission: K061278
- Applicant / Sponsor: Ophthalmos , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2006-05-16
Classification & Regulation
This clearance is catalogued under FDA product code HLJ and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.