Clearance Summary
RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER received FDA 510(k) clearance under submission number K061674, sponsored by Talia Technology , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2006-08-23.
- Submission: K061674
- Applicant / Sponsor: Talia Technology , Ltd.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2006-08-23
Classification & Regulation
This clearance is catalogued under FDA product code HLI and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.