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510(k) Data Aggregation
K Number
K152667Device Name
ATOVEN-Reusable Laser Fiber
Manufacturer
Date Cleared
2016-06-09
(266 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DIOTECH CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ATOVEN-Reusable Laser Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux. for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
The ATOVEN-Reusable Laser Fiber may be used with CW laser with wavelength range 810-1470 mm, a power range 5-15W, using an SMA905 connector.
Device Description
ATOVEN-Reusable Laser Fiber is free-beam delivery device that transits laser energy into intended direction. Fiber length is 2.9mters. This device can be connected with SMA905 connector and deliver to 810~1470;m. This device can be connected with cleared surgical use laser diode.
ATOVEN-Reusable Laser Fiber consists of optic fiber. The optic fiber also consists of connector, optical fiber. Fiber cable is made of the optical fiber that delivers the laser beam. And the fiber may be used any laser wavelength between 810~1470 m that have been cleared for surgical use diode laser. Outer diameter of fiber cable is 0.6mm and length is 2900 mm.
The fiber core and cladding for the subject device are made from silica which is the same material used in the predicate device. This device can be connected with SMA905 connector.
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K Number
K140458Device Name
DIOTECH LASER FIBER
Manufacturer
Date Cleared
2014-08-26
(183 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DIOTECH CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diotech Laser Fibers (400um, 600um) is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosties associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity. The Diotech Laser Fibers (400um, 600um) may be used with CW laser with wavelength range 810-1470mm, a power range 5-15W, using an SMA905 connector.
Device Description
Diotech Laser Fiber is free- beam delivery device that transits laser energy into intended direction. Fiber length is 2.9mters. And catheter tube length is 0.85meters. Catheter tube marked on per 10mm. This device can be connected with SMA905 connector and deliver to 810~1470m. This device can be connected with cleared surgical use laser diode. This device is single use only and sterilized by EO gas.
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