Merilas 100491, 100557, 100555, 100580

GUDID 03830074980048

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.

Ophthalmic solid-state laser system

• Primary Device ID: 03830074980048
• NIH Device Record Key: e9d1f339-de28-4114-b9b2-3ab32dd8ec4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merilas
• Version Model Number: Merilas 532 alpha, Merilas 532 / 577 / 810 shortpu
• Catalog Number: 100491, 100557, 100555, 100580
• 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	03830074980048 [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: 2025-11-24 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: 2025-11-24Merilas 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.
• 03830074980048 - Merilas: 2025-11-24 Merilas ophthalmic laser systems are solid-state, slit lamp-mounted devices designed for photocoagulation and other ophthalmic l