# K183647: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Surgical Technologies America
- Decided: Aug 9, 2019 after 226 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K936109 (1994). 34 ancestors in all.
12 later devices descend from it; 6 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170121: Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories, Lumenis, Ltd. (2017) Summary page 5.
- K103654: Vela XL, Starmedtec GmbH (2011) Summary page 5.

## Most influential descendants
- K211401: SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2021), 7 descendants of its own
- 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

## Recalls of this device
- Dec 4, 2023 · Class II · Z-0716-2024: The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper 
- Dec 4, 2023 · Class II · Z-0717-2024: The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper 
- Dec 1, 2023 · Class II · Z-0748-2024: Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential
- May 26, 2022 · Class II · Z-1296-2022: Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.

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

Source page: https://510kreport.com/device/K183647
Methodology: https://510kreport.com/methodology