510(k) K143307
K143307 is an FDA 510(k) premarket notification submitted by Rayner Intraocular Lenses , Ltd. for the device "RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector". The FDA issued a decision of Substantially Equivalent on December 18, 2014. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Rayner Intraocular Lenses , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2014
- Date Received
- November 18, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Folders And Injectors, Intraocular Lens (Iol)
- Device Class
- Class I
- Regulation Number
- 886.4300
- Review Panel
- OP
- Submission Type