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510(k) Data Aggregation
K Number
K984537Device Name
KERATOME SYSTEM, MODEL K3000
Manufacturer
INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.
Date Cleared
1999-05-14
(144 days)
Product Code
HMY
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Insight Technologies Instruments, Model K3000 Keratome System is designed to produce a corneal flap.
Device Description
Not Found
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K Number
K974243Device Name
KERATOME SYSTEM
Manufacturer
INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.
Date Cleared
1998-01-20
(69 days)
Product Code
HMY
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Insight Technologies Instruments, Model K-1000 Keratome System is designed to produce a corneal flap.
Device Description
The model K-1000 keratome features a high speed, low torque nitrogen driven motor, which drives a reciprocating surgical blade will be a single-use, disposable device that will be filed under a separate 510k. The keratome head is preset to produce a corneal resection approximately 160 microns in depth with the corresponding blade insertion and flap diameter of approximately 10.0mm. The model K-1000 keratome system is battery operated and may also operate from its charger. The power unit provides on/off footswitch controls for the keratome head and drive assembly, and suction to the suction ring. Analog gauges located on the front panel of the unit indicate nitrogen pressure and suction level supplying the appropriate connectors.
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