FOTONMEDIX

GUDID 06976487170007

Near Infrared phototherapy device emitting up to 45 W at 980 nm, 12.1 Inch LCD Touch Screen display

Fotonmedix Medical Laser Co., LTD

Musculoskeletal/physical therapy laser, professional

• Primary Device ID: 06976487170007
• NIH Device Record Key: e705cafb-433a-4de4-8289-22e3a14b32c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOTONMEDIX
• Version Model Number: LaserMedix4500U1
• Company DUNS: 602442900
• Company Name: Fotonmedix Medical Laser Co., LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976487170007 [Primary]

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2025-01-30
• Device Publish Date: 2025-01-22

On-Brand Devices [FOTONMEDIX]

• 06976487170007: Near Infrared phototherapy device emitting up to 45 W at 980 nm, 12.1 Inch LCD Touch Screen disp
• 06976487170090: Infrared and near infrared phototherapy device emitting up to 30 W at 810nm, 915nm, 940nm, 980n