Manufacturer
Olympus Surgical Technologies AmericaSOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
Olympus Surgical Technologies America
Product code GEX· 21 CFR 878.4810
Product code
Device details
FDA 510(k) registration fields
- K number
- K183647
- Device name
- SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-12-26
- Decision date
- 2019-08-09
- Submission type
- Traditional
- Technology type
- Thulium fiber(AI inferred)
- Clinical applications
- Surgical cuttingOtherVascular treatmentAcne treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
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 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 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 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.
Intended 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.
Device Description
The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is a thulium laser, producing a pulsed beam of coherent near-infrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The SOLTIVE Laser System is produced in two models, the SOLTIVE™ Premium SuperPulsed Laser and SOLTIVE™ Pro SuperPulsed Laser. The Premium has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz. A secondary, foldable screen is provided. The Pro can operate at a maximum power of 35 Watts and Frequency limited to 100Hz. Both systems are operated with a wireless footswitch or wired footswitch, and both systems can utilize an auxiliary video monitor to display operating parameters. The Premium and Pro Laser must be used with a SOLTIVE Laser Fiber, offered in diameters from 150 – 940 microns. The system includes: Laser console, Laser fibers – sterile single use and reusable, Foot pedal, wireless or wired, Accessories – power cord, HDMI cable, safety goggles/glasses, fiber cutter, fiber cleaver, fiber gripper.
Summary parsed at:2026-06-01 05:55:05 UTC
Predicate devices
2—
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Not ingested
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
K183647 references 2 predicate/reference devices
Cited as predicate
8SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
Medical Thulium Fiber Laser Systems (UroFiber 60Q)
Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
Tamburo Thulium Fiber Laser System
Patriot Duo
Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
8 submissions cite K183647 as a predicate
