Xtrallux™ Xtrallux™ Super Plus Reg SizeRecalls & reported problems

Xtrallux, LLC · Xtrallux™ Super Plus Hair Regrowth Cap - Photobiomodulating Device - Reg. Size · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860007783418), received between Dec 3, 2025 and Dec 23, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Overheating of Device2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 23, 2025Overheating of Device; Overheating of Device
ON 11/26/2025, XTRALLUX RECEIVED COMMUNICATION THAT A DEVICE WAS BECOMING HOT WITH SIGNS OF OVERHEATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23884173 ↗
MalfunctionDec 3, 2025Overheating of Device; Overheating of Device
ON 11/03/2025, XTRALLUX RECEIVED COMMUNICATION FROM A PATIENT CLAIMING THAT THE DEVICE WAS GETTING HOT ON THE PATIENT'S HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23711964 ↗

Device details

UDI-DI	`00860007783418`
Brand	Xtrallux™
Model	Xtrallux™ Super Plus Reg Size
Company	Xtrallux, LLC
Product code	OAP · Laser, Comb, Hair
Class	Class 2
FDA submission	K222364
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 27, 2023

Device type (GMDN): 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.

Other Laser, Comb, Hair devices

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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