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510(k) Data Aggregation
K Number
K172375Device Name
MicroSTAAR Injector System Cartridges
Manufacturer
STAAR Surgical Company
Date Cleared
2017-09-06
(30 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
STAAR Surgical Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroSTAAR® Injector System Cartridge, Model CQ is a device intended to fold and insert STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye.
Device Description
The MicroSTAAR Injector System Cartridge, Model CQ (also referred as "MicroSTAAR Injector CQ Cartridge" or "CQ Cartridge") is intended to facilitate the loading, folding and insertion of the STAAR Surgical Collamer® 3-piece Intraocular Lens (IOL) into the human eye following cataract extraction. The model CQ Cartridge is a single use device designed specifically to be used with the reusable MicroSTAAR MSI-PM or MSI-TM injector to deliver the STAAR Surgical Collamer® 3-piece (IOL). The CQ Cartridge is composed of polypropylene and is terminally sterilized using Ethylene Oxide.
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K Number
K152357Device Name
MicroSTAAR Injector System Cartridges
Manufacturer
STAAR Surgical Company
Date Cleared
2015-10-30
(71 days)
Product Code
KYB, MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
STAAR Surgical Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroSTAAR® Injector System (MSI) is a device intended to fold and insert STAAR® Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement into the human eye.
Device Description
The MicroSTAAR® Injector System Cartridge (MSI Cartridge) is designed to facilitate the loading, folding and delivery of Collamer® phakic and aphakic intraocular lenses (ICL/IOL) into the human eve through a small incision. There is one model of MSI Cartridge in this submission, SFC-45 cartridge. The SFC-45 Cartridge is designed to lock into a corresponding MicroSTAAR® Injector System. The cartridge has a loading area on one end and a tapered tip on the other. The SFC-45 has a funnel shape, with exposed flat loading areas, and was designed to work with the Collamer® 1piece lenses manufactured by STAAR Surgical.
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