Xtrallux™

GUDID 00860007783425

Xtrallux™ Super Plus Hair Regrowth Cap - Photobiomodulating Device - Large Size

Xtrallux, LLC

Hair growth laser device

• Primary Device ID: 00860007783425
• NIH Device Record Key: ad7b2bb0-c981-4e09-bc80-b8ae00878cc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xtrallux™
• Version Model Number: Xtrallux™ Super Plus
• 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	00860007783425 [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
• 00860007783456: Xtrallux® Laser Comb Alpha - Hair Regrowth Device