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510(k) Data Aggregation
K Number
K023045Device Name
MICRORUPTER V
Manufacturer
MERIDIAN AG
Date Cleared
2002-09-26
(14 days)
Product Code
LXS
Regulation Number
886.4392Why did this record match?
Product Code :
LXS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device will be used in ophthalmic applications, including:
- . Posterior Capsulotomy
- Peripheral Iridotomy .
- Pupillary Membranectomy .
Device Description
The MICRORUPTOR V is a Q-switched Nd:YAG laser system designed for use in ophthalmologic procedures. It has the form of a table containing supply and control electronics and supporting a headrest where the head of the patient is placed, as well as a movable housing that is controlled by a joystick. The housing comprises a biomicroscope with a slit-lamp illumination (Haag-Streit), a Qswitched Nd:YAG laser, a laser diode producing a red (635 nm) aiming beam and optical, mechanical and electronics elements necessary to control the parameters and geometry of the laser beams.
The integrated Q-switched Nd:YAG laser emits short pulses of light at wavelength of 1064 nm. This light is focused in the plane of observation of the ophthalmic microscope. The irradiance at the focal point is high enough to cause optical breakdown, thus permitting the disruption of tissues.
The MICRORUPTOR V allows the physician to adjust the energy delivered to the target tissue and to precisely control and visualize the position of the beam focus, thus allowing a precise and noninvasive dissection of tissues inside the eye of the patient.
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