LightForce XLi

GUDID 00854103007073

The LightForce XLi is a professional musculoskeletal/physical therapy laser emitting up to 40W at 810/980nm wavelengths. The LightForce XLi is indicated for emitting energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle. The XLi laser system includes a therapeutic laser console and optical delivery system. The optical delivery system consists of a flexible optical fiber connected to a hand piece with interchangeable treatment heads and provides motion feedback to the user. A custom software application allows the user to select from built-in treatment protocols that adjust dosage and wavelength based on patient characteristics and condition. The device also provides the ability to set custom treatment parameters including output power, treatment time, and pulse rate.

LITECURE LLC

Musculoskeletal/physical therapy laser, professional

• Primary Device ID: 00854103007073
• NIH Device Record Key: 9e8924be-806e-43fd-b817-41fcccffedcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LightForce XLi
• Version Model Number: LTS-4000-L
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854103007073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173067

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-12-13

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