DEVICE: GREEN LASER PHOTOCOAGULATOR SYSTEM (04987669100202)

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Device Identifier (DI) Information

GREEN LASER PHOTOCOAGULATOR SYSTEM
GYC-1000

NIDEK CO.,LTD.
04987669100202
GS1
1
The GREEN LASER PHOTOCOAGULATOR SYSTEM GYC-1000 is an ophthalmological photocoagulation system using a solid state laser (green laser beam) with a wavelength of 532nm. Like conventional laser photocoagulation systems, this system is used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty. Since the GYC-1000 uses a diode laser as its pumping light source, the efficient oscillation of the 532nm laser beam can be obtained. As the GYC-1000 can be used with various kinds of delivery units, the system can be applied to transpupillary photocoagulation using the slit lamp or indirect ophthalmoscope, and to intraocular photocoagulation using the endophotocoagulation probe.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
General/multiple surgical frequency-doubled solid-state laser system A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes.
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FDA Product Code

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Product Code Product Code Name
GEX Powered Laser Surgical Instrument
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Sterilization

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No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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No Device Sizes
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Device Status

In Commercial Distribution
June 24, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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1-800-223-9044
info@nidek.com
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