# K261964: Echolaser X4

- Pathway: 510(k) (Traditional)
- Applicant: Elesta S.P.A
- Decided: Aug 19, 2026 after 69 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: 18 generations back to K943450 (1995). 364 ancestors in all.
No later device cites it as a predicate yet.
0 of 365 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213594: Echolaser X4, Elesta S.P.A (2022) Summary page 6.
- K100558: Quanta Diode Laser System, Quanta System Spa (2010) Summary page 6.

## Indications for use
The ECHOLASER X4 laser system is indicated for use to cut, 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 1064 nm. Echolaser X4 laser system includes the following specific indications: Discectomy: - Percutaneous Lumbar Discectomy Gastrointestinal: - Tissue Ablation: Benign and malignant Neoplasm Prostatectomy: - Soft Tissue Coagulation: Benign Prostatic Hyperplasia (BPH prostatectomy) Pulmonary Surgery: - Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include: Benign and malignant pulmonary obstruction GENERAL SURGERY - Soft Tissue: - Tumors and Lesions - Tissue Ablation GENITOURINARY SURGERY Ablation and Hemostasis: - Superficial Urinary Bladder Tumors - Invasive Bladder Carcinoma GYNECOLOGICAL TISSUE ABLATION - Endometrial Ablation (menorrhagia) - Submucous Fibroids OTORHINOLARYNGOLOGY SURGERY - Soft Tissue: - Tumors and Lesions - Tissue Ablation

Source page: https://510kreport.com/device/K261964
Methodology: https://510kreport.com/methodology