MR Q supine 780090

GUDID 03830074980000

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.

Ophthalmic solid-state laser system

• Primary Device ID: 03830074980000
• NIH Device Record Key: b1289312-cb6f-4331-bb40-4a60dbb6bac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Q supine
• Version Model Number: MR Q supine
• Catalog Number: 780090
• 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	03830074980000 [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: 2025-11-24The 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.
• 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: 2025-11-24 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