# K260632: Laser Thermal Therapy Kit

- Pathway: 510(k) (Special)
- Applicant: Elesta S.P.A
- Decided: Mar 17, 2026 after 19 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K943450 (1995). 148 ancestors in all.
No later device cites it as a predicate yet.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230460: Laser Thermal Therapy Kit, Elesta S.P.A (2023) Summary page 5.
- K181510: Echolaser X4, El.En Electronic Engineering Spa (2018) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K260632
Methodology: https://510kreport.com/methodology