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510(k) Data Aggregation
K Number
K030891Device Name
SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK
Manufacturer
Date Cleared
2003-06-17
(88 days)
Product Code
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
SURGISTAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgistar 2400-LSK Microkeratome is indicated for use as a replacement blade in the Moria LSK-ONE Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
The Surgistar 2410-CB Microkeratome blade is indicated for use as a replacement blade in the Moria Carriazo Barraquer Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
The Surgistar 2420-M2 Microkeratome blade is indicated for use as a replacement blade in the Moria Carriazo Barraquer II Keratome also known as the M2. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
Device Description
The Surgistar 2400-LSK is a replacement microkeratome blade for the Moria LSK-ONE Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2400-LSK blades are single-use, disposable blades.
The Surgistar 2410-CB is a replacement microkeratome blade for the Moria Carriazo Barraquer Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2410-CB blades are single-use, disposable blades.
The Surgistar 2420-M2 is a replacement microkeratome blade for the Moria Carriazo Barraquer II Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2420-M2 blades are single-use, disposable blades.
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K Number
K992978Device Name
RICROKERATOME BLADE
Manufacturer
Date Cleared
1999-11-16
(74 days)
Product Code
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
SURGISTAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgistar Microkeratome is indicated for use as a replacement blade in the Chiron Vision Automatic Corneal Shaper Surgical Instrument (ACS). The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
Device Description
Replacement Stainless Steel Blade for Chiron Automatic Corneal Shaper Blade
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