Meridian Medical d.o.o.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

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• MR Q supine - The MR Q supine is a Q-switched Nd:YAG ophthalmic laser system designed for supine patient treatment, suitable for operating rooms and pediatric use. It delivers laser energy at 1064 nm with pulse durations around 4 ns. Energy levels range from 0.3 to 12 mJ (single pulse) and up to 32 mJ (triple pulse). The device features electronically controlled treatment offset settings: anterior (150 µm, 300 µm) and posterior (0 µm, 100 µm, 200 µm, 300 µm), enhancing precision and safety.The laser has a super Gaussian beam profile and dual red diode aiming beams (635 nm) for accurate targeting. It includes Haag-Streit binoculars with tilt adjustment (0–210 degrees), joystick control, and optional footswitch. The integrated CSO 9800 LED slit lamp (Zeiss type) offers magnification from 6x to 40x.The MR Q supine is compatible with various operating tables and includes fixtures for treating young children. Safety features include automatic wheel locking, keypad access, and audible alarms for offset selection. The system is air-cooled and compliant with IEC 60601-1, EN 60601-1-2, and MDD 93/42/EEC standards.Indications for use include posterior capsulotomy and peripheral iridotomy. The MR Q supine is designed to deliver precise and effective ophthalmic laser treatments in a compact and ergonomic format.

  Meridian Medical d.o.o.

  2025-10-20

• MR Q - The MR Q is a Q-switched Nd:YAG ophthalmic laser system designed for seated patient treatment in outpatient clinical environments. It emits laser pulses at a wavelength of 1064 nm with a pulse duration of approximately 4 nanoseconds. The energy output ranges from 0.3 to 12 mJ for single pulses and up to 32 mJ for triple pulses. The device includes electronically adjustable treatment offset settings: anterior (150 µm, 300 µm) and posterior (0 µm, 100 µm, 200 µm, 300 µm), allowing precise targeting and minimizing risk to adjacent ocular structures.The MR Q features a super Gaussian beam profile and dual red diode aiming beams (635 nm) for accurate visualization. It is equipped with Haag-Streit-style binoculars with tilt adjustment (0–210 degrees), joystick control, and an optional footswitch. The integrated CSO 9800 LED slit lamp (Zeiss type) provides magnification from 6x to 40x.The system is air-cooled and includes safety features such as keypad access and audible alarms for offset selection. It is compliant with IEC 60601-1, EN 60601-1-2, and MDD 93/42/EEC standards.Indications for use include posterior capsulotomy and peripheral iridotomy. The MR Q is designed to deliver precise and effective ophthalmic laser treatments in a compact and ergonomic format.

  Meridian Medical d.o.o.

  2025-10-20

• MR Q SLT - The MR Q SLT is a Q-switched Nd:YAG ophthalmic laser system designed for selective laser trabeculoplasty (SLT) procedures in seated patients. It emits laser pulses at a wavelength of 532 nm with a pulse duration of approximately 3 to 4 nanoseconds. The energy output is adjustable between 0.2 and 2.0 mJ, optimized for targeting pigmented trabecular meshwork cells while minimizing thermal damage to surrounding tissue.The system features dual red diode aiming beams (635 nm) for precise targeting and a super Gaussian beam profile for uniform energy distribution. It includes Haag-Streit-style binoculars with tilt adjustment (0–210 degrees), joystick control, and an optional footswitch. The integrated CSO 9800 LED slit lamp (Zeiss type) provides magnification from 6x to 40x.The MR Q SLT is air-cooled and includes safety features such as keypad access and audible alarms. It is compliant with IEC 60601-1, EN 60601-1-2, and MDD 93/42/EEC standards.Indications for use include selective laser trabeculoplasty for the treatment of open-angle glaucoma. The MR Q SLT is designed to deliver precise and effective laser therapy in a compact and ergonomic format.

  Meridian Medical d.o.o.

  2025-10-20

• Merilas - Merilas ophthalmic laser systems are solid-state, slit lamp-mounted devices designed for photocoagulation and other ophthalmic laser treatments. All models feature a compact design, air-cooled operation, and user-friendly interface with adjustable parameters for power, pulse duration, and repetition rate. Each system includes a slit lamp adapter, aiming beam, and ergonomic controls for precise treatment delivery.The product family includes four wavelength-specific models:Merilas 532 alpha: Continuous-wave laser emitting at 532 nm, used for retinal photocoagulation procedures such as panretinal and focal treatments.Merilas 532 shortpulse: Short-pulse laser at 532 nm, designed for subthreshold retinal therapy to reduce thermal damage while maintaining therapeutic effect.Merilas 577 shortpulse: Short-pulse laser at 577 nm, optimized for treating macular edema and central serous retinopathy with reduced light scattering and selective absorption.Merilas 810 shortpulse: Infrared short-pulse laser at 810 nm, intended for transscleral cyclophotocoagulation and other glaucoma-related procedures requiring deeper tissue penetration.All Merilas systems are compliant with IEC 60601-1, EN 60601-1-2, and applicable medical device directives. They are intended for use by trained ophthalmic professionals in clinical environments.

  Meridian Medical d.o.o.

  2025-10-20