510(k) K172375

MicroSTAAR Injector System Cartridges by STAAR Surgical Company — Product Code MSS

K172375 is an FDA 510(k) premarket notification submitted by STAAR Surgical Company for the device "MicroSTAAR Injector System Cartridges". The FDA issued a decision of Substantially Equivalent on September 6, 2017. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. STAAR Surgical Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2017
Date Received
August 7, 2017
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