Manufacturer
Elesta S.P.ALaser Thermal Therapy Kit
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K230460
- Device name
- Laser Thermal Therapy Kit
- Company
- Elesta S.P.A
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-02-21
- Decision date
- 2023-05-22
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Surgical cuttingVascular treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
3—
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Not ingested
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Not ingested
ECHOLASER X4
K230460 references 3 predicate/reference devices
Cited as predicate
1LASER THERMAL THERAPY KIT
1 submission cite K230460 as a predicate