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

• Primary Device ID: 00854103007035
• NIH Device Record Key: 5860f6ab-29ba-4721-ac13-a3e17a353d59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LightForce EXP
• Version Model Number: LTS-1500P
• Company DUNS: 858768943
• Company Name: LITECURE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com
• Phone: 1-877-627-3858
• Email: customer.service@litecure.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854103007035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123014

FDA Product Code

• PDZ: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-07

Devices Manufactured by LITECURE LLC

• 00854103007332 - Large Massage Ball: 2022-11-30 BDA Attachment head Large Ball
• 00854103007349 - Flat Window: 2022-11-30 BDA Attachment head Flat Window
• 00854103007295 - LightForce X: 2022-11-11 Infrared phototherapy device emitting up to 10 W at 810/980 nm, 7" display
• 00854103007318 - XL Cone: 2022-08-31 BDA Attachment XL Cone
• 00854103007325 - XL Rolling Pin: 2022-08-31 BDA Xl Rolling Pin Attachment
• 00854103007110 - Empower Delivery System: 2022-07-08 Basic Hand Piece (BHP)_600um Fiber Assy (White)
• 00854103007134 - Empower IQ Delivery System: 2022-07-08 Smart Hand Piece (SHP)_800um Fiber Assy v2
• 00854103007165 - Empower Delivery System: 2022-07-08 Legacy Hand Piece 800um Fiber Hand Piece w/ Finger Switch, Cool Gray