FibroLux 600-501

GUDID 00852556007008

Multi Radiance Medical

Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 00852556007008
• NIH Device Record Key: 2bed864b-1cd7-41ff-89bd-58bde909104f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FibroLux
• Version Model Number: FibroLux
• Catalog Number: 600-501
• Company DUNS: 826320694
• Company Name: Multi Radiance Medical
• Device Count: 1
• DM Exempt: false
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852556007008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212189

FDA Product Code

• NHN: Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-16
• Device Publish Date: 2022-11-08

Devices Manufactured by Multi Radiance Medical

• 00852556007350 - GameDay: 2023-08-02
• 00852556007367 - GameDay: 2023-08-02
• 00852556007008 - FibroLux: 2022-11-16
• 00852556007008 - FibroLux: 2022-11-16
• 00852556007336 - PainAway: 2021-09-15
• 00852556007343 - PainAway: 2021-09-15
• 00852556007305 - MR5: 2020-09-07
• 00852556007312 - MR5: 2020-09-07
• 00852556007329 - MR5: 2020-09-07