Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K232417
    Device Name
    MR Q; MR Q SUPINE; MR Q SLT
    Manufacturer
    Meridian AG
    Date Cleared
    2024-01-25

    (167 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Why 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
    Ask a Question
    K Number
    K231011
    Device 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
    886.4390
    Why 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
    Ask a Question
    K Number
    K160677
    Device Name
    MICRORUPTOR 6
    Manufacturer
    MERIDIAN AG
    Date Cleared
    2017-05-19

    (435 days)

    Product Code
    GEX, LXS
    Regulation Number
    878.4810
    Why 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
    Ask a Question
    K Number
    K113390
    Device Name
    LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
    Manufacturer
    MERIDIAN AG
    Date Cleared
    2012-02-14

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why 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.
    Ask a Question
    K Number
    K072823
    Device Name
    MERILAS 532A
    Manufacturer
    MERIDIAN AG
    Date Cleared
    2007-12-14

    (73 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Why 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.
    Ask a Question
    K Number
    K023045
    Device Name
    MICRORUPTER V
    Manufacturer
    MERIDIAN AG
    Date Cleared
    2002-09-26

    (14 days)

    Product Code
    LXS
    Regulation Number
    886.4392
    Why 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.
    Ask a Question

    Page 1 of 1