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510(k) Data Aggregation
K Number
K232417Device Name
MR Q; MR Q SUPINE; MR Q SLT
Manufacturer
Meridian AG
Date Cleared
2024-01-25
(167 days)
Product Code
HQF
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
Meridian AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MR Q and the MR SUPINE are intended to perform:
- Posterior capsulotomy -
- Iridotomy -
The MR Q SLT in YAG mode is intended to perform:
- Posterior capsulotomy -
- -Iridotomy
The MR Q SLT in SLT mode is intended to perform:
- Selective laser trabeculoplasty
Device Description
Not Found
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K Number
K231011Device Name
Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
Manufacturer
Meridian AG
Date Cleared
2023-09-12
(155 days)
Product Code
HQF, HOF
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
Meridian AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MERILAS 810 shortpulse laser is indicated for:
- Photocoagulation
- Iridotomy
- Trabeculoplasty
- Thermotherapy
The MERILAS 532 shortpulse laser is indicated for:
- Photocoagulation
- Iridotomv
- Trabeculoplasty
The MERILAS 577 shortpulse laser is indicated for:
- Photocoagulation
- Iridotomy
- Trabeculoplasty
Device Description
Not Found
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K Number
K160677Device Name
MICRORUPTOR 6
Manufacturer
MERIDIAN AG
Date Cleared
2017-05-19
(435 days)
Product Code
GEX, LXS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MERIDIAN AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Microruptor 6 Nd: Y AG Laser is indicated for:
- posterior capsulotomy,
- pupillary membranectomy
- peripheral iridotomy
Device Description
Microruptor 6 Nd: YAG Laser
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K Number
K113390Device Name
LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
Manufacturer
MERIDIAN AG
Date Cleared
2012-02-14
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MERIDIAN AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Laser Indirect Ophthalmoscope 500 (LIO-500) is intended for use in photocoagulating ocular tissue in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.
Device Description
The LIO-500 can be used on a 532 nm laser such as the MERILAS 532a or any other ophthalmic laser with 532 nm. The LIO-500 does not incorporate any contacts, displays or other user accessible functions. Its main purpose is the delivery of the laser light, generated by an ophthalmic treatment laser unit to the eye of the patient. For the observation of the treatment area the attached indirect ophthalmoscope (such as the Heine Omega 500 or the Keeler Vantage Plus / Keeler Vantage Plus LED) gets used.
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K Number
K072823Device Name
MERILAS 532A
Manufacturer
MERIDIAN AG
Date Cleared
2007-12-14
(73 days)
Product Code
HQF
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
MERIDIAN AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MERILAS 532a is indicated for use in retinal photocoagulation, iridotomy and laser trabeculoplasty.
Device Description
The methods for delivery of the laser treatment beam to the desired tissue in the eye are:
- Slit lamp delivery device (also identified as: slit lamp adapter) such as the SLA-. BMBQ
- Laser indirect ophthalmoscope .
- . Endo fiber
The delivery method can be altered by exchanging the appropriate delivery device and connecting it to the base laser unit. The Autokey connector which belongs to each delivery device ensures that the base laser unit always gets the necessary information about the attached delivery device. The required delivery device has to be connected to the base laser unit before turning on the base laser unit.
During the start up procedure the MERILAS 532« identifies the attached delivery device and internally sets the appropriate parameters. The MERILAS 532α laser itself has built in sensors which do not allow the laser to fire if the delivery device fitted is not suitable in anwav.
For better viewing of the status of the laser unit when space is limited the display unit including the input devices can be removed from the base laser unit and placed on a more convenient space where good access as well as good viewing is possible. The maximum distance the display unit can be placed away from the base laser unit is 1 m due to maximum cable length.
After adjusting the desired parameters on the display of the base laser unit the treatment mode can be selected. In the treatment mode the red aiming beam (635 nm), generated by a laser diode, gets started and indicates the user to which area the treatment beam will be released. The physician selects the target tissue by aiming the red aiming beam to the desired tissue before releasing the treatment pulse.
The treatment laser is a diode pumped Nd: YVO laser which gets frequency doubled by using a KTP crystal. It is radiating at 532 nm. The transmission of the laser light gets achieved by focusing the laser light into an optical fiber and transmitting it to the delivery device. Laser power up to 2.5 W can be delivered out of the fiber. The laser delivery time can be adjusted from 10 ms up to 5 s.
The system can be operated from a 90-260 VAC, 50/60Hz single-phase power outlet. The mechanics of the MERILAS 532« is build out of anodized aluminium, painted sheet metal, and copper.
The optional slit lamp adapter SLA-BMBQ guides the laser beam from the laser unit into the illumination set of a slit lamp and focuses to the desired treatment area. The diameter of the spot can be adjusted in a range from 50 um to 5 mm by turning the dial wheel at the slit lamp adapter.
The mechanics of the SLA-BMBQ is build out of anodized aluminium.
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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?
Applicant Name (Manufacturer) :
MERIDIAN AG
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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