Clearance Summary
P200DTx received FDA 510(k) clearance under submission number K142897, sponsored by Optos Plc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2015-01-16.
- Submission: K142897
- Applicant / Sponsor: Optos Plc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2015-01-16
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.