DEVICE: Multicolor Laser Photocoagulator (04987669100080)
Device Identifier (DI) Information
Multicolor Laser Photocoagulator
MC-500
In Commercial Distribution
NIDEK CO.,LTD.
MC-500
In Commercial Distribution
NIDEK CO.,LTD.
The NIDEK Multicolor Laser Photocoagulator MC-500 is a laser photocoagulator for ophthalmology with the light source of wavelengths 647, 577, and 532 nm. As the conventional laser photocoagulators, the MC-500 can be used for retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity, and retinal detachment, or for laser iridotomy and laser trabeculoplasty for treatment of glaucoma.
The device incorporates two types of lasers (diode-pumped solid state laser and laser diode) which enable efficient obtainment of laser beam oscillation of each wavelength. As the conventional device, various types of laser delivery units can be used. Therefore, transpupillary photocoagulation can be performed using various delivery units such as slit lamps and binocular indirect ophthalmoscope.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HQF | Laser, Ophthalmic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
2ff51677-de3c-448a-b7ec-d8ceccde40a3
March 29, 2018
2
June 24, 2016
March 29, 2018
2
June 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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