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510(k) Data Aggregation
K Number
K190210Device Name
Tear Pool Dissolvable Punctum Plugs
Manufacturer
AlphaMed Inc
Date Cleared
2019-10-24
(262 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
AlphaMed Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tear Pool Dissolvable Punctum Plugs are designed to provide for temporary occlusion of the tear drainage system.
Punctum Plugs are indicated for:
- * 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 ocular surgery to prevent complications due to dry eyes
- * To evaluate treatment of ocular dryness
- * To evaluate the dry eye component of ocular surface diseases
Device Description
The Tear Pool Dissolvable Punctum Plug is an ophthalmic device commonly referred to as a punctum plug. It is designed to be inserted by a practitioner into the canaliculus to temporarily restrict the natural lubricating tears from draining off the surface of the eye.
This treatment is prescribed for temporary occlusion in the 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.
Tear Pool Dissolvable Punctum Plugs are cylindrical in shape. Approximately 2.0mm in length and are available in two sizes: 0.4mm and 0.5mm. Each plug is composed of polydioxanone(PDO). The plug is dyed with an approved color additive, D & C Violet No. 2.
A Tear Pool Dissolvable Punctum Plug is mounted on a specially designed insertion tool and placed into a plastic tray then sealed with a Tyvek® cover. The primary package is sent to the sterilizer for Ethylene Oxide sterilization. Two sterile trays, one IFU, two chart labels and one silica gel packet are sealed in a pouch and placed in a shelf box.
The Pre-Loaded Tear Pool Dissolvable Punctum Plugs are available in the following models and diameters and are 2.0mm in length
Model# 20-5304 0.4mm
Model# 20-5305 0.5mm
The device is make from Polydioxanone(PDO). The plugs are violet in color.
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K Number
K091240Device Name
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
Manufacturer
ALPHAMED INC.
Date Cleared
2009-10-23
(179 days)
Product Code
HOZ
Regulation Number
886.4790Why did this record match?
Applicant Name (Manufacturer) :
ALPHAMED INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AlphaMed Surgical Spears are intended to absorb fluids from the operative field during ophthalmic surgery
Device Description
Not Found
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