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510(k) Data Aggregation
K Number
K060372Device Name
INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
Manufacturer
INTRA LASE CORP.
Date Cleared
2006-08-16
(184 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INTRA LASE 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 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 corneal flap in patients undergoing LASIK surgery or other o 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 corneal resections and incisions. 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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