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510(k) Data Aggregation
K Number
K970727Device Name
MPORT FOLDABLE LENS PLACEMENT SYSTEM
Manufacturer
CHIRON VISION CORP.
Date Cleared
1997-12-17
(292 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
CHIRON VISION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mport™ Foldable Lens Placement System is a Class I device indicated for compressing and inserting a Soflex™ (formerly Chiroflex II) series multi-piece intraocular lens into the eye during small incision cataract surgery.
Device Description
The Mport™ Foldable Lens Placement System is a device designed to compress and insert a Soflex™ multipiece foldable intraocular lens into the eye during normal small incision cataract surgery. The Mport™ is a single use only disposable device. The Mport™ materials the same as those materials used in the lens/patient contacting cartridge of the predicate device (polypropylene).
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K Number
K972808Device Name
HANSATOME MICROKERATOME
Manufacturer
CHIRON VISION CORP.
Date Cleared
1997-10-24
(88 days)
Product Code
HNO
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
CHIRON VISION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hansatome™ microkeratome is a precision-manufactured instrument indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
Device Description
The Hansatome™ microkeratome is a precision-manufactured instrument designed for cutting a precise corneal disc of preselected thickness and diameter. The device is intended for use in performing lamellar corneal resections. The Hansatome™ Microkeratome materials are similar to those used in the predicate device.
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K Number
K960414Device Name
SYNERGIST POWER PACK
Manufacturer
CHIRON VISION CORP.
Date Cleared
1996-04-24
(86 days)
Product Code
HQC
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
CHIRON VISION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synergist™ Power Pack is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required.
Device Description
The Synergist™ Power Pack is an accessory device that operates in conjunction with currently marketed Phaco Emulsifier Aspirator Systems used in ophthalmic surgery. The Synergist™ replaces the ultrasonic handpiece of the host console. As such, it is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required. The Synergist™ delivers two distinct surgical capabilities: 1) load compensating ultrasonic handpiece power, and 2) Tmesis™ multifunction handpiece capability.
The Synergist™ Power Pack consists of:
Power Pack Console
Connector Cables
Tmesis™ multi-function handpiece,
Adjunct Footswitch
Ultra Tip™ Pack in various configurations
The Synergist™ Power Pack utilizes the programmable features of the Phaco Emulsifier host console but contains no software or firmware. It is controlled by the amplified signal of the host console by measuring the handpiece output of the host console and establishing that exact power level to the connected handpiece. Displayed power levels and energy summations on the host console are precisely maintained by the Synergist™. The Power Pack neither provides or utilizes power from the host console.
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