Clearance Summary
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector received FDA 510(k) clearance under submission number K143307, 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 2014-12-18.
- Submission: K143307
- Applicant / Sponsor: Rayner Intraocular Lenses , Ltd.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2014-12-18
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.