Xtrallux™

Basic Information

• Brand Name: Xtrallux™
• Primary DI: 00860007783418
• Version / Model: Xtrallux™ Super Plus Reg Size
• Company Name: Xtrallux, LLC
• Labeler DUNS: 036992284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-17
• Public Version: 1
• Public Version Date: 2023-11-27
• Public Version Status: New
• Public Device Record Key: f4d5a015-91b5-4de0-9a34-a02463f629dc

Device Description

Xtrallux™ Super Plus Hair Regrowth Cap - Photobiomodulating Device - Reg. Size

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAP	Laser, Comb, Hair	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47417	Hair growth laser device	An electronic, portable, head-worn or hand-operated device intended to be operated by a layperson affected by scalp hair loss (i.e., receding hairline/baldness due to androgenic alopecia) to stimulate hair growth on the scalp through the application of scheduled low-level laser therapy (LLLT). The device uses individual laser diodes to direct laser light at the scalp and may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is intended for use in the home or a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007783418	GS1

Premarket Submissions

Submission Number	Supplement Number
K222364	000