Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The LASER THERMAL THERAPY KIT is used to direct laser energy to soft tissue, to necrotize and coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery, in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopaedics, pulmonology, radiology, and urology at a wavelength of 1064nm. The LDF is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm.
The LASER THERMAL THERAPY KIT is used to direct laser energy to soft tissue, to necrotize and coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery, in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopaedics, pulmonology, radiology, and urology at a wavelength of 1064nm.
The LASER THERMAL THERAPY KIT consists of a Fiber Optic for PLA (272μm core quartz-quartz fiber with distal end outer diameter 420μm and NA 0.2) and an introducer needle (21G). The device is sterile and single use.
Summary parsed at:2026-06-01 05:32:43 UTC
