MR Q 780000

GUDID 03830074980017

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.

Ophthalmic solid-state laser system

• Primary Device ID: 03830074980017
• NIH Device Record Key: f262c854-8c86-41b7-b869-32541948dc09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Q
• Version Model Number: MR Q
• Catalog Number: 780000
• Company DUNS: 644472151
• Company Name: Meridian Medical d.o.o.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03830074980017 [Primary]

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-11-24
• Device Publish Date: 2025-10-20

Devices Manufactured by Meridian Medical d.o.o.

• 03830074980000 - MR Q supine: 2025-11-24 The MR Q supine is a Q-switched Nd:YAG ophthalmic laser system designed for supine patient treatment, suitable for operating roo
• 03830074980017 - MR Q: 2025-11-24The 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.
• 03830074980017 - MR Q: 2025-11-24 The MR Q is a Q-switched Nd:YAG ophthalmic laser system designed for seated patient treatment in outpatient clinical environment
• 03830074980024 - MR Q SLT: 2025-11-24 The MR Q SLT is a Q-switched Nd:YAG ophthalmic laser system designed for selective laser trabeculoplasty (SLT) procedures in sea
• 03830074980048 - Merilas: 2025-11-24 Merilas ophthalmic laser systems are solid-state, slit lamp-mounted devices designed for photocoagulation and other ophthalmic l