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510(k) Data Aggregation
K Number
K111460Device Name
OPTO HYALUS GREEN LASER
Manufacturer
Date Cleared
2012-08-20
(452 days)
Product Code
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
OPTO ELETRONICA S/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Opto Hyalus Green Laser is indicated for retinal photocoagulation. Used for the following ophthalmic medical condition and treatment:
- Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroids, including:
- Proliferative and nonproliferative diabetic retinopathy
- Choroidal neovascularization
- Branch retinal vein occlusion
- The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments
- Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma
Device Description
The Opto Hyalus Green Laser solid state, frequency-doubled, green Nd;YAG surgical laser system is an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm.
The equipment consists of three encoders which enable the physician to adjust the pulse duration, the laser power and the interval between successive pulses. All information is displayed on a color display 240x324 pixels TFT technology. On this display there is a touch-screen film responsible for the navigation software and by setting preferences, such as loudness, intensity laser sighting and display brightness.
Physicians have the option of applying single pulses or pulse trains previously adjusted. Power levels ranging from 50mW up to 2000mW, with resolution of 10mW. The duration can be set between 10ms and 1000 ms with a resolution of 10ms. The interval between pulses can be set between 50ms and 3000ms with 10ms resolution or can be set to single pulse (in this case, the range is set to zero).
The Opto Hyalus Green Laser beam has a wavelength of 532nm, which is in the visible spectrum and is a green light. A red aiming beam is used to position the treatment green beam prior to delivery.
The Opto Hyalus Green Laser is a solid state, Optical Pumped Semiconductor surgical laser.
It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm.
Compatible delivery devices include: slit lamp adapters/, laser indirect ophthalmoscopes (LIO) and Probe. All these accessories are specific for Opto Hyalus Green Laser.
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