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

Olympus Surgical Technologies America

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

8

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

K183647 references 2 predicate/reference devices

Cited as predicate

8

8 submissions cite K183647 as a predicate