LightForce EXPi LTS-2500Recalls & reported problems

Litecure LLC · Mains powered, infrared phototherapy and nail laser phototherapy device emitting up to 25 W at 980/810nm in CW or pulsed modes with a 10" touch screen display. · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854103007059), received between Mar 20, 2019 and Mar 20, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 16, 2026.

Most reported problems

Device problems

Improper or Incorrect Procedure or Method1

Patient problems

Radiation Burn1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMar 20, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
PATIENT EXPERIENCED LESION ON SHOULDER SEVERAL DAYS AFTER TREATMENT DUE TO INCORRECT PROCEDURE BY OPERATOR. THE PROVIDED DOSE WAS GREATER THAN THE RECOMMENDED LEVEL LEADING TO OVEREXPOSURE. TREATMENT TECHNIQUE DID NOT FOLLOW IFU. ALSO, PATIENT HAD REDUCED SENSATION DUE TO EXISTING CONDITION THAT WAS NOT DISCLOSED PRIOR TO TREATMENT.
Patient problems: Radiation Burn
MAUDE report 8437526 ↗

Device details

UDI-DI	`00854103007059`
Brand	LightForce EXPi
Model	LTS-2500
Company	Litecure LLC
Product code	PDZ · Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 8, 2022

Device type (GMDN): Musculoskeletal/physical therapy laser, professional

An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.

Other Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis devices

LightForce EXP LTS-1500P
Litecure LLC · Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
1 report

All Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page