Xtrallux™

GUDID 00860007783432

Xtrallux™ Turbo Pro Hair Regrowth Cap - Photobiomodulating Device

Xtrallux, LLC

Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device

• Primary Device ID: 00860007783432
• NIH Device Record Key: a45b32f7-c9bc-4ce1-8a97-6fedabe36c8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xtrallux™
• Version Model Number: Xtrallux™ Turbo Pro
• Company DUNS: 036992284
• Company Name: Xtrallux, LLC
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007783432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222364

FDA Product Code

• OAP: Laser, Comb, Hair

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: 2023-11-27
• Device Publish Date: 2023-11-17

On-Brand Devices [Xtrallux™]

• 00860007783449: Xtrallux™ Extreme RX Hair Regrowth Cap - Photobiomodulating Device
• 00860007783432: Xtrallux™ Turbo Pro Hair Regrowth Cap - Photobiomodulating Device
• 00860007783425: Xtrallux™ Super Plus Hair Regrowth Cap - Photobiomodulating Device - Large Size
• 00860007783418: Xtrallux™ Super Plus Hair Regrowth Cap - Photobiomodulating Device - Reg. Size
• 00860007783401: Xtrallux™ Alpha Hair Regrowth Cap - Photobiomodulating Device