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510(k) Data Aggregation
K Number
K053511Device Name
DA VINCI FEMTOSECOND SURGICAL LASER
Manufacturer
SIE LTD SURGICAL INSTRUMENT ENGINEERING
Date Cleared
2006-03-10
(84 days)
Product Code
GEX, HNO
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SIE LTD SURGICAL INSTRUMENT ENGINEERING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Da Vinci™ Femtosecond Surgical 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 Da Vinci™ Femtosecond Surgical Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the Da Vinci™ Femtosecond Surgical Laser is achieved through nonlinear absorption of infrared laser light and subsequent disintegration of tissue, created by focused ultrashort pulses which are delivered through a lens while fixating the eye under a vacuum. The complete Da Vinci™ Femtosecond Surgical Laser system consists of the following functional units: 1. Base Station (BS), integrating the Laser Unit, Fast Scan Unit (FS), and Fixed Mirror Articulating Arm (FMAA) 2. Handpiece (HP), integrating the Slow Scan Unit (SS) and the Cutting Lens 3. Accessories, comprising Suction Ring, Distance Foil, Vacuum Tube with Strainer and Handpiece Cover. The Da Vinci™ Femtosecond Surgical Laser is movable on four rollers. Two rollers can be locked by a mechanical brake. For movement inside the clinic, HP and FMAA can be locked in a secured transport position.
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