DEVICE: Norlase LYNX photocoagulator (05700002165466)
Device Identifier (DI) Information
Norlase LYNX photocoagulator
N008-9200
In Commercial Distribution
Norlase ApS
N008-9200
In Commercial Distribution
Norlase ApS
The Norlase LYNX photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
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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62161 | Ophthalmic diode laser system |
An electrically-powered device assembly in which input energy is used to excite a diode to emit a low-power and/or high-power therapeutic laser beam intended for ophthalmic surgery (e.g., ocular incisions, ocular photocoagulation, iridectomy, vitrectomy). Some types may also include an air pump to disperse subretinal fluid in certain procedures (e.g. retinal detachment repair). The laser utilizes a diode/semiconductor chip (as the active medium); it does not include femtosecond pulsing, or fundus imaging technology.
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Active | false |
32729 | Indirect binocular laser ophthalmoscope |
An electrically-powered, head-worn, ophthalmic device used for the stereoscopic examination and laser treatment of the eye, particularly the retina. It typically consists of a headband, a built-in light with aperture control for adjustment of the illumination field, convergence controls to synchronize the illumination and examination beams, a delivery mirror, filters to protect the surgeon against incidental laser-beam reflection, and a power-supply cable for the lighting, and a fibreoptic cable to convey the laser beam. This device is connected to an appropriate laser for delivery of laser energy.
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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
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
7b63adb7-1de7-45d7-8bf2-4ba767e9d54a
November 07, 2024
1
October 30, 2024
November 07, 2024
1
October 30, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined