# K221306: SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jan 27, 2023 after 267 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K936109 (1994). 36 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211401: SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories), Gyrus Acmi, Inc. (2021) Summary page 5.
- K183647: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories), Olympus Surgical Technologies America (2019) Summary page 5.

## Most influential descendants
- 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
- K262877: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2026), 0 descendants of its own
- K250504: Leonardo Duster (2025), 0 descendants of its own

## Recalls of this device
- Aug 13, 2024 · Class II · Z-0135-2025: The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or uni
- Aug 13, 2024 · Class II · Z-0134-2025: The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or uni
- May 31, 2024 · Class II · Z-2505-2024: Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
- May 31, 2024 · Class II · Z-2504-2024: Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
- May 31, 2024 · Class II · Z-2506-2024: Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
- Jan 29, 2024 · Class II · Z-1384-2024: A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
- Jan 29, 2024 · Class II · Z-1385-2024: A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
- Dec 4, 2023 · Class II · Z-0718-2024: Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed p

## 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) • Laser Enucleation of the Prostate (LEP) • Laser Ablation of the Prostate (LAP) • Transurethral Incision of the Prostate (TUIP) • Condylomas • Urethral/ureteral strictures • Lesions of external genitalia • 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 renal 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, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.

Source page: https://510kreport.com/device/K221306
Methodology: https://510kreport.com/methodology