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510(k) Data Aggregation
K Number
K230460Device Name
Laser Thermal Therapy Kit
Manufacturer
Date Cleared
2023-05-22
(90 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Elesta SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LASER THERMAL THERAPY KIT used to direct laser energy to soft tissue, to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the perical sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.
Device Description
The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The LASER THERMAL THERAPY KIT consist of a Fiber Optic for PLA (272μm core quartz fiber with distal end outer diameter 420um and NA 0.2) and an introducer needle (21G). The device is sterile and single use.
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K Number
K213594Device Name
ECHOLASER X4
Manufacturer
Date Cleared
2022-05-03
(172 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ELESTA SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ECHOLASER X4 laser system is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation 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, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.
Device Description
The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via optical fibers . The operator can use 1 to 4 (or 1 to 2 in case of two channels model) fibers simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.
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