# K211401: SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

- Pathway: 510(k) (Special)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jun 3, 2021 after 28 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K936109 (1994). 35 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183647: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories), Olympus Surgical Technologies America (2019) Summary page 6.

## Most influential descendants
- K221306: SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories (2023), 4 descendants of its own
- K242191: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2024), 3 descendants of its own
- K261221: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2026), 1 descendant of its own
- K232568: IPG Medical Family of Thulium  Fiber Lasers, Surgical Fibers, and Accessories (2024), 1 descendant of its own
- K262877: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2026), 0 descendants of its own

## Recalls of this device
- Jun 30, 2021 · Class II · Z-2294-2021: Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets

## Indications for use
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 Prostrate (LRP)e Laser Enucleation of the Prostate (LEP)* Laser Ablation of the Prostate (LAP)* Transurethral Incision of the Prostate (TUIP) » Condylomase Urethral stricturese Lesions of external genitalias Bladder neck incisions (BNI)* Ablation and resection of bladder tumors, urethral tumors, and ureteral tumorse 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 haemostasis) including: » Appendectomy * Angiodysplasia * Polyps ¢ Colorectal cancer * Biopsy ¢ Telangiectasias * Gall Bladder calculi * Telangiectasias of the Osler-Weber-Renu disease ¢ Biliary/Bile duct calculi « Vascular Malformation * Ulcers * Gastritis * Gastric ulcers * Esophagitis « Duodenal ulcers * Esophageal ulcers * Non Bleeding Ulcers * Varices * Pancreatitis ¢ Colitis * Haemorrhoids « 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

Source page: https://510kreport.com/device/K211401
Methodology: https://510kreport.com/methodology