Clearance Summary
RAYSERT PLUS INJECTOR received FDA 510(k) clearance under submission number K141091, sponsored by Rayner Intraocular Lenses , 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 2014-05-28.
- Submission: K141091
- Applicant / Sponsor: Rayner Intraocular Lenses , Ltd.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2014-05-28
Classification & Regulation
This clearance is catalogued under FDA product code MSS and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.