# K230460: Laser Thermal Therapy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Elesta S.P.A
- Decided: May 22, 2023 after 90 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: 2 generations back to K963081 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053087: Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter System, Biotex, Inc. (2006) Summary page 6.

## Most influential descendants
- K260632: Laser Thermal Therapy Kit (2026), 0 descendants of its own

## Indications for 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 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/K230460
Methodology: https://510kreport.com/methodology