Clearance Summary
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 received FDA 510(k) clearance under submission number K091507, sponsored by Rayner Intraocular Lenses , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2009-12-04.
- Submission: K091507
- Applicant / Sponsor: Rayner Intraocular Lenses , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2009-12-04
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.