SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Urology:
- Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
- Laser Resection of the Prostate (LRP)
- Laser Enucleation of the Prostate (LEP)
- Laser Ablation of the Prostate (LAP)
- Transurethral Incision of the Prostate (TUIP)
- Condylomas
- Urethral strictures
- Lesions of external genitaliae
- Bladder neck incisions (BNI)
- Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
- Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
- Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications:
- Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
- Endoscopic fragmentation of calculi
- Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology:
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy
- Angiodysplasia
- Polyps
- Colorectal cancer
- Biopsy
- Telangiectasias
- Gall Bladder calculi
- Telangiectasias of the Osler-Weber-Rendu disease
- Biliary/Bile duct calculi
- Vascular Malformation
- Ulcers
- Gastritis
- Gastric ulcers
- Esophagitis
- Duodenal ulcers
- Esophageal ulcers
- Non Bleeding Ulcers
- Varices
- Pancreatitis
- Colitis
- Hemorrhoids
- Mallory-Weiss tear
- Cholecystectomy
- Gastric Erosions
- Benign and Malignant Neoplasm

Gynecology:
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.

The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

The proposed SOLTIVE Laser System with application software Version 2.1 has the identical intended use, design, and scientific technology as the predicate SOLTIVE Laser System (K183647). The subject modification is solely an update to the application software to add a Ureteral Stone preset to the menu of factory presets, and other enhancements. There are no new issues of safety or effectiveness with the proposed device. No material changes were made to the SOLTIVE Laser System cleared under K183647.