510(k) K143307

RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector by Rayner Intraocular Lenses , Ltd. — Product Code MSS

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