Thulium Fiber Laser (FiberLAZE+, FiberLAZE)

Allengers Global Healthcare Private Limited

Country / region:India (IN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

View Summary PDF

Product code

GEX
21 CFR 878.4810

Predicate devices

2

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

2

K242987 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K242987 as a predicate