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510(k) Data Aggregation
K Number
K053333Device Name
EAGLEVISION GELLANSERTS, MODEL REF 0040
Manufacturer
EAGLE VISION, INC.
Date Cleared
2006-05-02
(152 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EAGLE VISION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EagleVision Gellansert is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to:
- Determine the potential effectiveness of permanent occlusion,
- Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases,
- Increase retention of ocular medications
- Temporarily treat contact lens intolerance secondary to dry eye, and
- Treat dry eye after surgery.
Device Description
EagleVision Gellanserts are intended to temporarily block tear drainage by occlusion of the canaliculus. EagleVision Gellanserts are made of a hydrophilic, resorbable material, and are designed to expand only laterally after insertion into the canaliculus, so that only one size is needed to occlude most patients' lacrimal systems. The EagleVision Gellanserts are designed to expand and fit virtually all patient anatomies from 0.3mm up to 1.1 mm, so multiple inserts in one canaliculus are generally not necessary. There are five inserts per sterile pouch, so that one EagleVision Gellansert can be placed in each punctum with one additional EagleVision Gellansert in case one is dropped or mishandled.
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K Number
K030353Device Name
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
Manufacturer
EAGLE VISION, INC.
Date Cleared
2003-04-25
(81 days)
Product Code
OKS, HNL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EAGLE VISION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and their delivery systems. They are intended for use in lacrimal system reconstruction. This includes, but is not limited to, treatment of: epiphora in infants or adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.
Device Description
The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and delivery systems.
The MonoStent™ Monocanalicular Stents consist of a length of silicone tubing, with a silicone punctum pluq molded perpendicularly onto one end of the tubing. A stainless steel stylet is provided with the stent to assist in the insertion of the silicone tubing.
The EagleVision® Lacrimal Intubation Set is comprised of stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of medical grade silicone tubing that is attached to malleable stainless steel probes. The intubation set allows for probing and stenting as a one step procedure.
The EagleVision® K Type Lacrimal Intubation Set is comprised of stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of silicone probes attached with a silicone rod.
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K Number
K991130Device Name
FLEXPLUG
Manufacturer
EAGLE VISION, INC.
Date Cleared
1999-04-20
(18 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EAGLE VISION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EagleVision FlexPlug Punctum Plug intended use is punctal and canalicular occlusion in patients with chronic dry eye.
Device Description
FlexPlug Punctum Plug
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