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510(k) Data Aggregation
K Number
K032400Device Name
LAFACI
Manufacturer
VISION PRO, L.L.C.
Date Cleared
2004-05-07
(277 days)
Product Code
FYD
Regulation Number
878.5070Why did this record match?
Applicant Name (Manufacturer) :
VISION PRO, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LaFaci Surgical System is intended for use during LASIK procedures. The LaFaci Surgical System consists of a reusable Handpiece, Surgical Cart, and disposable Tubing Accessories. The LaFaci System provides ocular fixation and containment of surgical field, corneal flap placement and flap re-positioning, and is used for ophthalmic plume aspiration, fluid aspiration, and the delivery of micro filtered air to the surgical field.
Device Description
LaFaci™ Surgical System combines multiple functions commonly utilized during LASIK into a single hand piece allowing for the delivery of sterile balanced saline irrigation solution to the surgical field, fluid aspiration from the surgical field, delivery of micro-filtered air to the surgical field, and plume evacuation from the surgical field. All of these functions are generated and delivered from the LaFaci™ Surgical Cart to the LaFaci™ Handpiece through fourlumen surgical tubing.
LaFaci™ Handpiece also provides manual ocular fixation, and provides a platform for the temporary placement of the corneal flap during ablation. In addition the platform can be manually pivoted over the corneal bed thereby providing a spatula means to reposition the flap onto the stromal bed.
The LaFaci™ Surgical Cart accessories include an adjustable instrument tray, and handpiece tubing swing arm that provides sterile setup and operational efficiency during surgery. The LaFaci™ Surgical Cart disposable accessories include the LaFaci Handpiece Tubing Set (sterile) and the LaFaci Smoke/Fluid Evacuation Accessories (non-sterile).
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