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510(k) Data Aggregation
K Number
K991124Device Name
VISIJET HYDROKERATOME, MODEL 50
Manufacturer
Date Cleared
2000-10-20
(567 days)
Product Code
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
VISIJET, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VisiJet Hydrokeratome is intended for use in performing anterior lamellar circular corneal resections.
The VisiJet Hydrokeratome is indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
Device Description
The VisiJet Hydrokeratome - Model 50 is a non-oscillating, non-mechanical microkeratome which utilizes a continuous high-velocity beam of sterile water for injection to effect a lamellar resection of the cornea. The major elements of this microkeratome are a system console, a footswitch and a handpiece with interchangeable suction rings. The operating principle of the water beam microkeratome is based on the ability to create high levels of static hydraulic pressure that is directed across the cornea, effecting a lamellar resection.
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