Manufacturer
Elesta S.P.ALASER THERMAL THERAPY KIT
Country / Region:Italy (IT)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K260632
- 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
- 2026-02-26
- Decision date
- 2026-03-17
- Submission type
- Special
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Surgical cuttingOtherVascular treatmentSkin resurfacing
- 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 vaporize, ablate, 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, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.
Intended Use
The LASER THERMAL THERAPY KIT is used to direct laser energy to soft tissue, to vaporize, ablate, 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, plastic 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 energy is transmitted via the fiber optic, which is introduced into the skin and tissue site percutaneously using the introducer needle. The LASER THERMAL THERAPY KIT is composed of a Fiber Optic for PLA (272 m core quartz-quartz fiber with distal end outer diameter 420 m and NA 0.2, and 2 m length) and an introducer needle (21G). The device is sterile and single use. Fiber optic and Introducer are packed individually.
Summary parsed at:2026-06-01 05:19:27 UTC
Predicate devices
2ECHOLASER X4
Laser Thermal Therapy Kit
K260632 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K260632 as a predicate