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510(k) Data Aggregation
K Number
K161673Device Name
LacriPro Punctum Plug
Manufacturer
LACRIMEDICS, INC.
Date Cleared
2016-11-18
(155 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LACRIMEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LacriPro plugs may be used to:
- Treat Dry Eye Syndrome
- Treat ocular dryness secondary to contact lens use
- Enhance the efficacy of topical ocular medications
- Prevent complications due to dry eyes after surgery
- Treat the Dry Eye component of ocular surface diseases
Device Description
The proposed device is an ophthalmic device commonly referred to as a punctum plug. It is designed to be placed by a practitioner into the punctal opening (upper/lower) to restrict the natural lubricating tears from being pumped off the surface of the eye. This treatment is prescribed for long-term treatment of certain eye conditions collectively referred to as Dry Eye Disease, as well as the dry eye component of ocular surface diseases and other conditions of tear insufficiency. LacriPro Punctum Plugs have a distal tip, a proximal cap and a body (tubular shaft) connecting the tip to the cap. The cap is designed to rest on the opening of the puncta after the tip and body are inserted into the canalicular canal. The cap has one or more recesses (depending on diameter) for retaining tear fluid. The plug has a passage extending in the distal direction from an opening in the proximal cap to facilitate mounting on an insertion tool. The LacriPro Punctum Plugs are available in the following models, diameters and lengths: Model # 1833 0.6mm (1.42mm length) x-small; Model # 1835 0.7mm (1.52mm length) Small; Model # 1837 0.8mm (1.60mm length) Medium; Model # 1839 0.9mm (1.78mm length) Large. The device is made from silicone liquid rubber MED 4870 by Nusil, Inc. The plugs are clear, or translucent.
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K Number
K140026Device Name
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
Manufacturer
LACRIMEDICS, INC.
Date Cleared
2014-06-03
(148 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LACRIMEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VisiPlugST provide temporary occlusion of the tear drainage system. VisiPlugST may be used as a diagnostic aid to determine the potential effectiveness of long-term occlusion, to temporarily enhance the efficacy of topical medication or ocular lubricants, after surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD).
Device Description
The proposed device is an ophthalmic device commonly referred to as a punctum plug. It is designed to be placed by a practitioner into the horizontal canaliculus to restrict the natural lubricating tears from being pumped off the eye.
VisiPlugST provides temporary occlusion of the tear drainage system. The device may be used as a diagnostic aid to determine the potential effectiveness of long-term occlusion, to temporarily enhance the efficacy of topical medications or ocular lubricants, after surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD).
VisiPlugST plugs are cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Each plug is cut from a monofilament strand of Glycoprene® MG23, a synthetic surgical grade polymer composed of poly(glycolide-co-trimethylene carbonate-co-caprolactone). The monofilament is dyed with an approved color additive, Green D & C 6 (CAS# 128-80-3; 0.1% by weight). Titanium dioxide is added to the polymer to make the plugs opaque, providing a satisfactory means with which to determine the plug's presence or absence following insertion by a practitioner.
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K Number
K030300Device Name
OPAQUE HERRICK LACRIMAL PLUG
Manufacturer
LACRIMEDICS, INC.
Date Cleared
2003-05-09
(100 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LACRIMEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® is intended to block the canaliculus for the relief of dry eye syndrome.
Dissolvable Opaque Herrick Lacrimal Plug® may be used:
- As a diagnostic aid to determine the potential effectiveness of Occlusion Therapy with non-dissolvable plugs.
- To temporarily enhance the efficacy of topical medications or ocular lubricants.
- After ocular surgery to prevent complications due to dry eyes.
- To evaluate treatment of ocular dryness secondary to contact lens use.
- In the treatment of Dry Eye Syndrome and the dry eye components of varying Ocular Surface Diseases.
Device Description
The Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® provides temporary occlusion of the tear drainage system. The plug is supplied in various sizes ranging from 0.2 mm to 0.5mm in diameter. The length is approximately 1.75 mm. The dissolvable (suture material) plug is composed of any one of the following: (1) a copolymer of L-lactide and epsilon -caprolactone (PCL); (2) polydioxanone (PDO); (3) copolymers of glycolic acid and trimethylene carbonate.
The proposed device is supplied as a single use component for use in treatment of dry eye syndrome. The device is supplied sterile and is intended for SINGLE USE ONLY.
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K Number
K021831Device Name
OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB
Manufacturer
LACRIMEDICS, INC.
Date Cleared
2002-07-01
(27 days)
Product Code
LZU, LZV
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LACRIMEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OPAQUE Herrick Lacrimal Plugs may be used in the treatment of:
· Dry Eye symptoms:dryness, redness, itching, burning, intermittont tearing or foreign body sensation.
· For treatment of ocular dryness secondary to contact lens use.
· To enhance the efficacy of topical ocular medications.
· After surgery to provent complications due to Dry Fye.
· For the Dry Eye component of: conjunctivitis, keratitis, corncal ulcer, pterygium blepharitis, red lid margins, recurrent chalazion. corneal erosion, filamentary keratitis and other eye diseases.
OPAQUE Horrick Lacrimal Plugs are indicated by the patient's positive response to The Lacrimal Efficiency Test TM with dissolvable plugs (Lacrimedics).
Device Description
Not Found
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K Number
K001737Device Name
OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM
Manufacturer
LACRIMEDICS, INC.
Date Cleared
2000-06-19
(12 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LACRIMEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K963501Device Name
HERRICK ULTIMATE PUNCTUM PLUG
Manufacturer
LACRIMEDICS, INC.
Date Cleared
1997-04-14
(223 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LACRIMEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used to enhance retention of eye fluids by occlusion of one or more punctum, reducing lacrimal flow. Useful for treatment of dry eye and other conditions where enhancement of tear retention is indicated
Device Description
A flexible silicone ophthalmic device designed to fit and be retained in the punctum.
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K Number
K963708Device Name
HERRICK ULTIMATE PUNCTUM PLUG
Manufacturer
LACRIMEDICS, INC.
Date Cleared
1997-04-14
(210 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LACRIMEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used to enhance retention of eye fluids by occlusion of one or more punctum, reducing lacrimal flow. Useful for treatment of dry eye and other conditions where enhancement of tear retention is indicated.
Device Description
A flexible silicone ophthalmic device designed to fit and be retained in the punctum.
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