Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The LTS-1000/1500/2500/4000 devices emit 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 LTS-2500/4000 devices are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis.
810 nm and 980 nm wavelength: The LTS-1000/1500/2500/4000 devices emit 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. 980 nm wavelength: The LTS-2500/4000 devices are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis.
The LightForce LTS Model 1000, 1500, 2500, and 4000 are diode laser devices that emit energy at wavelengths of 810 nm ± 20 nm and/or 980 nm ± 20 nm. They are designed for both therapeutic and surgical applications, providing topical heating and facilitating procedures such as hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue.
Summary parsed at:2026-06-01 05:56:27 UTC
