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Found 13 results
510(k) Data Aggregation
K Number
K061404Device Name
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
2006-08-07
(80 days)
Product Code
OKS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FCI OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated in initial surgery in the treatment of monocanalicular lacerations and stenoses requiring intubation. Further indications are: Congenital lacrimal duct obstructions Canalicular lacerations After treatment of canaliculitis with concretions when curettage of a canaliculus has been performed. After clacryocystorhinostomy Epiphora
Device Description
Not Found
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K Number
K061398Device Name
SNUG PLUG PUNCTUM PLUG
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
2006-07-11
(53 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FCI OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ocular dryness. The Snug Plug punctum plug is used to occlude the punctum in the treatment of ocular dryness.
Device Description
Not Found
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K Number
K041869Device Name
SELF RETAINING BICANALICULUS INTUBATION SET
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
2004-11-18
(132 days)
Product Code
OKS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FCI OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bicanalicular intubation is indicated in treatments of epiphora in adults (not to be used in infants), particularly in cases of:
- Meatic pathologies (meatic atresia)
- Canalicular pathologies (canalicular stricture)
Device Description
Self-Retaining Bicanaliculus Intubation Set
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K Number
K023758Device Name
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
2003-09-17
(313 days)
Product Code
OKS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FCI OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Transnasal Lacrimal Stent is indicated in treatments of epiphora treated by dacryocystorhinostomy. Dacryocystorhinostomy (DCR) is the common surgical procedure used to correct nasolacrimal duct obstruction.
Device Description
Not Found
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K Number
K023400Device Name
FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
2003-08-22
(317 days)
Product Code
HPZ
Regulation Number
886.3320Why did this record match?
Applicant Name (Manufacturer) :
FCI OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mesh wrapped Bioceramic orbital implants are designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.
Device Description
Mesh Wrapped Bioceramic Orbital Implant
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K Number
K030054Device Name
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
2003-02-26
(51 days)
Product Code
HJK, HMX, HNN
Regulation Number
886.1385Why did this record match?
Applicant Name (Manufacturer) :
FCI OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable Vitrectorny Set is used in the context of vitrectorny procedures. The self-blocking infusion cannula with infusion tubing provides the saline solution or balanced saline solution throughout the procedure, ensuring that the eye retains its tonicity. No sutures are required. The knife is used for making a calibrated and non-leaking incision into which the self-blocking infusion cannula is inserted. The lens, used with microscope, facilitates visualization of the retina by canceling the corneal diopter. An edge, which has a frosted ring on its upper side to avoid edge glare effects, allows users to position and move the lens on the cornea with forceps.
Device Description
Not Found
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K Number
K992294Device Name
BIOCERAMIC ORBITAL IMPLANT
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
2000-04-19
(287 days)
Product Code
HPZ
Regulation Number
886.3320Why did this record match?
Applicant Name (Manufacturer) :
FCI OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a primary implant for patients who present with eye disease or severe damage such that the eye must be enucleated or eviscerated.
An existing orbital implant that is malfunctioning or not satisfying the patient in terms of performance, may call for a secondary implant procedure to install a bio-ceramic orbital implant.
Device Description
Bio-ceramic Orbital Implant
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K Number
K991238Device Name
FCI CRAWFORD PROBE INTUBATION SETS
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
1999-07-08
(87 days)
Product Code
OKS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FCI OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Epiphora in infants or adults, particularly in cases of canalicular pathologies (stenosis, obstruction or laceration) dacryocysorhinostomy (conventional or laser) imperforation of the nasolacrimal duct in an infant
Device Description
Not Found
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K Number
K980816Device Name
RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
1998-09-18
(199 days)
Product Code
HQX
Regulation Number
886.3340Why did this record match?
Applicant Name (Manufacturer) :
FCI OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision
Device Description
Not Found
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K Number
K980822Device Name
TITANIUM PEG SYSTEM
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
1998-07-09
(128 days)
Product Code
MQU
Regulation Number
886.3320Why did this record match?
Applicant Name (Manufacturer) :
FCI OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This system is designed to drill hydroxyapatite orbital implants and place a motility peg for coupling to the artificial eye. It may also be used to replace a previous sleeve or a previous peg.
Device Description
Not Found
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