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510(k) Data Aggregation
K Number
K242397Device Name
LYNX Photocoagulator
Manufacturer
Norlase Aps
Date Cleared
2024-10-25
(73 days)
Product Code
HQF
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
Norlase Aps
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Norlase LYNX Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
Device Description
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K Number
K201623Device Name
LION Photocoagulator
Manufacturer
Norlase ApS
Date Cleared
2020-08-11
(57 days)
Product Code
HQF, GEX
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
Norlase ApS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
Device Description
The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator system was developed to utilize advancements in visible green semiconductor (diode) laser technology and to provide a compact design to be incorporated in a lightweight headset worn by the physician. The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator system consists of an indirect ophthalmoscope headpiece, a headset laser enclosure/casing, a wireless user interface tablet, a footswitch with a battery, and a cable extending from the footswitch to the headset. The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator system is controlled by the wireless user interface tablet that allows the physician to set the desired parameters for treatment. A shrouded footswitch is connected to the headset to control the emission of laser light and the battery to power the device illumination and laser source. The physician uses the headset to locate the area to be treated and after setting the appropriate parameters, targets the desired tissue utilizing a visible red aiming beam. The foot switch is pressed by the physician to deliver therapeutic green laser light to the targeted tissue. Eye safety filters are built into the laser unit to protect the physician's eyes while providing a clear view of the target area.
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K Number
K190083Device Name
Leaf Photocoagulator
Manufacturer
Norlase ApS
Date Cleared
2019-05-03
(106 days)
Product Code
HQF
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
Norlase ApS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Norlase Leaf Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
Device Description
The Norlase Leaf device consists of a laser unit, a wireless control unit and a foot switch. The laser unit must be attached to the Doctors own compatible slit lamp to work as a full system. The Norlase Leaf Device is controlled by the wireless control unit that allows the Doctor to set the desired parameters for treatment. A shrouded foot switch is connected to the laser unit to control the emission of laser light.
The Doctor will use the user supplied slit lamp to identify the area to be treated and after setting the appropriate parameters, will target the ophthalmic tissue utilizing a visible red aiming laser. The foot switch will be pressed by the Doctor to deliver therapeutic green laser light to the target tissue. A mechanically fixed eye safety filter is built into the Laser Unit to protect the Doctor from any stray or reflected green laser light travelling along the visual path of the slit lamp.
The Norlase Leaf device consists of the following modules:
- -Laser unit + power supply + power cable
- Foot switch + cable -
- Control unit (Tablet computer with installed Software) + power supply + USB cable -
The wavelength of the treatment beam is centered around ~520 nm, and the maximum optical output power is 1.5W (to tissue). The laser is operated in continuous wave (CW) mode and electronically pulsing the laser output power to achieve durations from 50 usec to 1 second. Laser parameters are controlled by a Control Unit (tablet) User Interface that utilizes a touchscreen control to select or change a setting. Voice Control of selected parameters is an optional feature that can assist in the increment or selection of a parameter,
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