810nm 2W Cluster (5x400mW)

GUDID 05060494130244

S2120 810nm 2W Cluster (5x400mW)

THOR PHOTOMEDICINE LIMITED

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• Primary Device ID: 05060494130244
• NIH Device Record Key: 38f9cfca-c53e-4604-a0f5-d31ab8308ef0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 810nm 2W Cluster (5x400mW)
• Version Model Number: 2.3
• Company DUNS: 856233908
• Company Name: THOR PHOTOMEDICINE LIMITED
• 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: 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	05060494130244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033923

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [810nm 2W Cluster (5x400mW)]

• 05060494130244: S2120 810nm 2W Cluster (5x400mW)
• 05060494130237: S1120 810nm 2W Cluster (5x400mW)