DEVICE: YAG laser combination delivery unit (YC-1800) (04987669100103)
Device Identifier (DI) Information
YAG laser combination delivery unit (YC-1800)
17367-0000
In Commercial Distribution
NIDEK CO.,LTD.
17367-0000
In Commercial Distribution
NIDEK CO.,LTD.
This combination delivery unit is need to comprise the combination system which enables radiation of the red, yellow, or green laser beam or YAG laser beam while performing the observation with the slit lamp of the YAG laser system. This delivery unit is mounted on the slit lamp of the YAG laser system and connected to the NIDEK Multicolor Laser Photocoagulator MC-500 using the MC connecting cable and fiber optic cable. The combination system allows selection between photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and YAG laser beam (wavelength: 1064 nm (pulse laser)). In addition, they are selected easily by changing the optical path of the laser beam with the laser select
lever, and various kinds of safety devices are integrated into the system to make sure that only the selected laser beam is radiated. This combination delivery unit is the only delivery unit that can be connected both to the NIDEK Multicolor Laser Photocoagulator MC-500 and the NIDEK Ophthalmic YAG Laser System YC-1800.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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36150 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HQF | Laser, Ophthalmic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
600424b0-4ea8-4e6f-bc5b-26d31469c64f
March 29, 2018
2
February 01, 2017
March 29, 2018
2
February 01, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-223-9044
info@nidek.com
info@nidek.com