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Found 8 results
510(k) Data Aggregation
K Number
K073404Device Name
IFS LASER SYSTEM
Manufacturer
INTRALASE CORP.
Date Cleared
2008-04-25
(143 days)
Product Code
GEX, HNO
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INTRALASE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iFS Laser System is an ophthalmic surgical laser indicated for use:
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments
- In lamellar keratoplasty and corneal harvesting
- In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty
Device Description
The iFS Laser System is a precision ophthalmic surgical laser designed for use as an ophthalmic surgical laser indicated for use:
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea:
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments;
- In lamellar keratoplasty and corneal harvesting;
- In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the . creation of a penetrating cut/incision for penetrating keratoplasty.
Corneal dissection with the iFS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical which are delivered through a disposable applanation lens assembly while fixating the eye under low vacuum.
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K Number
K063682Device Name
INTRALASE FUSION LASER
Manufacturer
INTRALASE CORP.
Date Cleared
2007-02-09
(60 days)
Product Code
GEX, HNO
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INTRALASE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntraLase Fusion™ Laser is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
Device Description
The IntraLase Fusion Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections and incisions. The cutting action of the IntraLase Fusion Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens assembly while fixating the eye under low vacuum.
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K Number
K041893Device Name
INTRALASE FS LASER
Manufacturer
INTRALASE CORP.
Date Cleared
2005-07-29
(381 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INTRALASE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The INTRALASE® FS Laser is an ophthalmic surgical laser with the following indications for use:
- In patients undergoing surgery or other treatment requiring intial lamellar resection of the cornea
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of the corneal ring segments
- In lamellar keratoplasty and corneal harvesting
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
- In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty
Device Description
The INTRALASE FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar and full thickness or penetrating corneal resections. The cutting action of the INTRALASE FS Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
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K Number
K031960Device Name
INTRALASE FS LASER
Manufacturer
INTRALASE CORP.
Date Cleared
2003-09-29
(96 days)
Product Code
GEX, HNO
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INTRALASE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The INTRALASE® FS is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LA'SIK surgery or other treatment requiring initial lamellar resection of the cornea.
Device Description
The INTRALASE FS Laser is a precision ophthalmic surqical laser designed for use in performing lamellar corneal resections. The cutting action of the INTRALASE FS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
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K Number
K013941Device Name
PULSION FS LASER KERATOME
Manufacturer
INTRALASE CORP.
Date Cleared
2002-02-27
(90 days)
Product Code
GEX, HNO
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INTRALASE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pulsion™ FS is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
Device Description
The Pulsion FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the PULSION FS Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
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K Number
K002890Device Name
INTRALASE 600C LASER KERATOME
Manufacturer
INTRALASE CORP.
Date Cleared
2001-08-09
(328 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INTRALASE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001211Device Name
MODIFICATION TO INTRALASE 600C LASER KERATOME
Manufacturer
INTRALASE CORP.
Date Cleared
2000-12-04
(234 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INTRALASE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993153Device Name
INTRALASE 600C LASER KERATOME
Manufacturer
INTRALASE CORP.
Date Cleared
1999-12-17
(87 days)
Product Code
GEX, HNO
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INTRALASE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntraLase 600C Laser Keratome is an ophthalmic surgical laser indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
Device Description
The IntraLase 600C Laser Keratome is a precision ophthalmic surgical laser designed for cutting a precise corneal disc of preselected thickness and diameter. The device is intended for use in performing anterior lamellar corneal resections. The materials, basic scientific concepts and physical properties of the IntraLase 600C are similar to those of the ISL OC2000, while the indication for use and the intended use are identical to those of the Hansatome microkeratome.
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