Manufacturer
Allengers Global Healthcare Private LimitedThulium Fiber Laser (FiberLAZE+, FiberLAZE)
Allengers Global Healthcare Private Limited
Country / Region:India (IN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K242987
- Device name
- Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
- Country / Region
- India(IN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-09-26
- Decision date
- 2024-12-17
- 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
Thulium Fiber Laser is intended for incision, excision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue in the following indications: Urology, Lithotripsy, Gastroenterological surgery and Gynecological Surgery. Urology - Ablation of Benign Prostatic Hyperplasia (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 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 - 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
Intended Use
Thulium Fiber Laser is intended for incision, excision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue in the following indications: Urology, Lithotripsy, Gastroenterological surgery and Gynecological Surgery. Urology: Ablation of Benign Prostatic Hyperplasia (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 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.
Device Description
Thulium Fiber Laser is a laser system that emits a wavelength of 1.94 μm with a laser output power up to 60W and 35W respectively. Laser radiation is delivered to the patient via an optical fiber. The main subsystems of the device are the laser, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user to select device settings. Laser emission is triggered by a footswitch. The device is intended to be used together with delivery optical fiber that separately received a FDA clearance for an intended use.
Summary parsed at:2026-06-01 05:29:27 UTC
Predicate devices
2SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
Fiber Dust
K242987 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K242987 as a predicate
