AccessGUDID - DEVICE: LightForce EXPi (00854103007059)

GUDID

Device Identifier (DI) Information

Brand Name: LightForce EXPi
Version or Model: LTS-2500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LITECURE LLC

Primary DI Number: 00854103007059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 858768943 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60409	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.	Active	false
60388	Nail laser phototherapy unit	A portable, mains electricity (AC-powered), laser-emitting device intended to treat nail fungal infection (onychomycosis) using low-level laser treatment (LLLT). It typically consists of an electronic unit with a digital display and a treatment platform where the foot/hand is placed to receive LLLT; it typically includes protective eyewear. It is intended to be used by a healthcare provider in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PDZ	Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
ILY	Lamp, Infrared, Therapeutic Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: afc8d452-ab5e-42b2-8b32-ccbffe253c20
Public Version Date: December 08, 2022
Public Version Number: 9
DI Record Publish Date: July 24, 2017