OrthoPulse

GUDID 91201180900032

Biolux Technology GmbH

Red-light phototherapy unit, professional

• Primary Device ID: 91201180900032
• NIH Device Record Key: 40e029ee-7d1a-42d0-8e00-388be9731026
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoPulse
• Version Model Number: OrthoPulse Lite
• Company DUNS: 300613819
• Company Name: Biolux Technology GmbH
• 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: false
• Manufacturing Date: false
• 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	91201180900032 [Primary]

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: 2026-03-19
• Device Publish Date: 2026-03-11

On-Brand Devices [OrthoPulse]

• 09120118090029: OPi
• 09120118090067: OrthoPulse 2.0 Standard
• 09120118090074: OrthoPulse 2.0 Extended
• 91201180900032: OrthoPulse Lite