Search Results
Found 7 results
510(k) Data Aggregation
K Number
K090161Device Name
EPIPHANY INJECTION SYSTEM
Manufacturer
STAAR SURGICAL CO.
Date Cleared
2009-06-09
(138 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
STAAR SURGICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Epiphany Injector System is a device intended to fold and insert STAAR Surgical Company aspheric three piece Collamer®, Model CQ2015A, and aspheric three piece silicone intraocular lenses, Model AQ2015A, for surgical placement in the human eye.
Device Description
The single use, disposable Epiphany Injector System is a delivery system for intraocular lenses (IOLs) for surgical placement in the human eye. The two main materials used in the manufacturer of this injector system will be polycarbonate and polypropylene. All product is also supplied "STERILE."
Ask a Question
K Number
K073586Device Name
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
Manufacturer
STAAR SURGICAL CO.
Date Cleared
2008-03-13
(84 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
STAAR SURGICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroSTAAR ™ Indigo Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.
Device Description
Not Found
Ask a Question
K Number
K073591Device Name
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
Manufacturer
STAAR SURGICAL CO.
Date Cleared
2008-03-13
(84 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
STAAR SURGICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroSTAAR ™ MSI Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.
Device Description
Not Found
Ask a Question
K Number
K032412Device Name
RE-USEABLE MICROSTAAR INJECTOR, MSI-S
Manufacturer
STAAR SURGICAL CO.
Date Cleared
2004-06-10
(310 days)
Product Code
KYB
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
STAAR SURGICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Collamer 3 Piece IOL Injector, is an intraocular lens guide used to ford and into the capsular bag or ciliary sulcus following cataract extraction.
Device Description
The Collamer 3 Piece Injector is made of titanium alloy designed for inserting intraocular lenses into the human eye following cataract extraction. The Collamer 3 Piece Injector materials and mechanical behavior are similar to those used with the predicate device.
Ask a Question
K Number
K020734Device Name
SURGE-FREE ASPIRATION ADAPTER
Manufacturer
STAAR SURGICAL CO.
Date Cleared
2002-05-16
(71 days)
Product Code
HQC
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
STAAR SURGICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surge-free Aspiration Adapter is a filter protected flow restriction orifice used during cataract surgery to prevent/neutralize vacuum surges in the aspiration line.
Device Description
The Surge-free Aspiration Adapter is a filter protected flow restriction device intended to be placed between the handpiece and aspiration tubing used during phacoemulsification surgery. The Surge-free Aspiration Adapter prevents/neutralizes vacuum surges in the aspiration line resulting from the sudden clearing of occlusions.
Ask a Question
K Number
K983129Device Name
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
Manufacturer
STAAR SURGICAL CO.
Date Cleared
1998-12-04
(87 days)
Product Code
KYB
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
STAAR SURGICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable MicroSTAAR™ Injector (Model MSI-P1) is a device used to fold and insert STAAR Surgical UV-ELASTICT™ silicone lenses for surgical placement in the human eye.
The Disposable MicroSTAAR™ Injector is a device used to fold and insert STAAR Surgical Company UV-ELASTIC™ single-piece silicone lenses for surgical placement in the human eye.
Device Description
The Disposable MicroSTAART™ Injector (Model MSI-P1) is used to fold and insert STAAR Surgical UV-ELASTICTM silicone intraocular lenses for surgical placement in the human eye. Like other MicroSTAAR injectors it provides a sterile tubular pathway through a surgical incision, over the iris and into either the ciliary sulcus or the capsular bag of the eye. The Disposable MicroSTAART™ Injector (Model MSI-P1) is made from plastic and the inner dimensions of the delivery pathway, as well as the outer dimensions of the portion that contacts the eye tissues are identical to STAAR Surgical Company's currently marketed injection systems. The Disposable MicroSTAART™Injector (Model MSI-P1) is provided sterile and is designed for single use.
Ask a Question
K Number
K980696Device Name
FOAM TIP INJECTOR
Manufacturer
STAAR SURGICAL CO.
Date Cleared
1998-09-11
(200 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
STAAR SURGICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Foam Tip™ Injector is a device used to fold and insert STAAR Surgical UV-ELASTIC™ silicone lenses for surgical placement in the human eye.
Device Description
STAAR Surgical Company's Foam Tip™ Injector is used to fold and insert STAAR Surgical UV-ELASTIC™ silicone intraocular lenses for surgical placement into the human eye. The new Foam Tip™ Injector utilizes the same design principles (i.e. a plunger pushing or threaded mechanism) to push the IOL through a cartridge for injection into the eye as the existing MicroSTAART™ injectors. The new injector system differs from the MicroSTAART™ injector in that it contains a disposable Foam Tip™ plunger insert which may be attached to the sterilized injector body prior to lens loading. This attachable Foam Tip™ plunger insert is encapsulated inside a holder that protects the sponge from damage. The holder acts to guide the plunger as it slides into the injector body and performs as a wrench to remove the plunger from the injector once the lens has been implanted. Once the sponge portion of the foam plunger insert is hydrated, it enables the surgeon to have greater control in ejecting the lens properly through the cartridge and into the eye. Like the existing MicroSTAAR™ injectors, the new Foam Tip™ Injector body is provided sterile and can be resterilized for multiple use. The new Foam Tip™ plunger insert is also provided sterile but is intended for single use only.
Ask a Question
Page 1 of 1