OrthoPulse OPi2E-100

GUDID 09120118090074

Biolux Technology GmbH

Red-light phototherapy unit, professional

• Primary Device ID: 09120118090074
• NIH Device Record Key: 27c1aae3-4c16-4b15-bfca-3e5fd859fad6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoPulse
• Version Model Number: OrthoPulse 2.0 Extended
• Catalog Number: OPi2E-100
• Company DUNS: 300613819
• Company Name: Biolux Technology GmbH
• 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	09120118090074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230905

FDA Product Code

• PLH: Orthodontic Led Accessory

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: 2023-09-06
• Device Publish Date: 2023-08-29

On-Brand Devices [OrthoPulse]

• 09120118090029: OPi
• 09120118090067: OrthoPulse 2.0 Standard
• 09120118090074: OrthoPulse 2.0 Extended