FDA UDI In Commercial Distribution 🇺🇸 United States

LightForce XPi

DI: 00854103007103 · Model: LTS-2500-L-S8 · LITECURE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
LightForce XPi
Primary DI
00854103007103
Version / Model
LTS-2500-L-S8
Company Name
LITECURE LLC
Labeler DUNS
858768943
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-10-30
Public Version
3
Public Version Date
2022-12-08
Public Version Status
Update
Public Device Record Key
8e1d2e8e-42fc-4d1c-a17e-f28f22b385dd

Device Description

Mains powered, infrared phototherapy device emitting up to 25 W at 980/810nm in CW or pulsed modes with a 10" touch screen display. Compatible with New Empower IQ delivery system.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ILY Lamp, Infrared, Therapeutic Heating

GMDN Terms

Code Name
60409 Musculoskeletal/physical therapy laser, professional

Identifiers

Type ID
Primary 00854103007103