LightForce EXP

GUDID 00854103007035

Mains powered, infrared and nail laser phototherapy device emitting up to 15 W at 810 & 980 nm and up to 25 W at 980 nm. At 810 & 980 nm, the LightForce EXP (LTS-1500P) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation. At 980 nm, the EXP is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes, Trichophyton rubrum and Tmentagrophytes, and/or yeasts Candida albicans, etc.). The EXP is a portable medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch, or optional foot switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.

LITECURE LLC

Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit Nail laser phototherapy unit
Primary Device ID00854103007035
NIH Device Record Key5860f6ab-29ba-4721-ac13-a3e17a353d59
Commercial Distribution StatusIn Commercial Distribution
Brand NameLightForce EXP
Version Model NumberLTS-1500P
Company DUNS858768943
Company NameLITECURE LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com
Phone1-877-627-3858
Emailcustomer.service@litecure.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854103007035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-02-07

Devices Manufactured by LITECURE LLC

00854103007332 - Large Massage Ball2022-11-30 BDA Attachment head Large Ball
00854103007349 - Flat Window2022-11-30 BDA Attachment head Flat Window
00854103007295 - LightForce X2022-11-11 Infrared phototherapy device emitting up to 10 W at 810/980 nm, 7" display
00854103007318 - XL Cone2022-08-31 BDA Attachment XL Cone
00854103007325 - XL Rolling Pin2022-08-31 BDA Xl Rolling Pin Attachment
00854103007110 - Empower Delivery System2022-07-08 Basic Hand Piece (BHP)_600um Fiber Assy (White)
00854103007134 - Empower IQ Delivery System2022-07-08 Smart Hand Piece (SHP)_800um Fiber Assy v2
00854103007165 - Empower Delivery System2022-07-08 Legacy Hand Piece 800um Fiber Hand Piece w/ Finger Switch, Cool Gray
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.