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510(k) Data Aggregation

    K Number
    K242987
    Device Name
    Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
    Date Cleared
    2024-12-17

    (82 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Allengers Global Healthcare Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Thulium Fiber Laser is intended for incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue in the following indications: Urology, Lithotripsy, Gastroenterological surgery and Gynecological Surgery. Urologv - · Ablation of Benign Prostatic Hyperplasia (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 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, 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 um 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 select device settings. Laser emission is triggered by a footswitch.
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    K Number
    K231718
    Device Name
    Holmium Medical Laser
    Date Cleared
    2023-08-18

    (66 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Allengers Global Healthcare Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Holmium Medical Laser and its fiber optic delivery system are in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectory, Gynecology, ENT, Pulmonary Surgery and General Surgery. Urology Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including: - · Urethral Strictures - · Bladder Neck Incisions (BNI) - · Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors, - · Ablation of Benign Prostatic Hypertrophy (BPH), - · Transurethral incision of the prostate (TUIP) - · Holmium Laser Resection of the Prostrate (HoLRP) - · Holmium Laser Enucleation of the Prostate (HoLEP) - · Holmium laser Ablation of the Prostate (HoLAP) - · Condylomas - · Lesions of external genitalia Lithotripsy and Percutaneous Urinary Lithotripsy · Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, - monohydrate and calcium oxalate - · dehydrate stones. - · Endoscopic fragmentation of kidney calculi. - · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed. Gastroenterology Open and endoscopic Gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including: - · Appendectomy - Polyps - · Biopsy - · Gall Bladder calculi - · Biliary/Bile duct calculi - · Ulcers - · Gastric ulcers - · Duodenal ulcers - · Non Bleeding Ulcers - · Pancreatitas - · Haemorrhoids - · Cholecystectomy - · Benign and Malignant Neoplasm - · Angiodysplasia - · Colorectal cancer · Telangiectasias - · Telangiectasias of the Osler-Weber-Renu disease - Vascular Malformation - · Gastritis - · Esophagitis - · Esophageal ulcers - Varices - · Colitis - · Mallory-Weiss tear - · Gastric Erosions Arthroscopy Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including: - · Ligament and tendon Release - · Contouring and sculpting of articular surfaces - · Capsulectomy in the Knee - · Chondreplasty in the Knee - · Debridement of inflamed synovial tissue - Chondromalacia Ablation - · Chondromalacia and tears - · Plica Removal - · Meniscectomy - · Loose Body Debridement - · Lateral retinecular release Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including · Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy Gynaecology Open and laparoscopic gynaecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue ENT Endoscopic endonasal surgery (incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including: - · Endonasal/sinus Surgery - · Partial turbinectomy - · Polypectomy - · Dacryocystorhinostomy - · Frontal Sinusotomy - · Ethmoidectomy - · Maxillary antrostomy - · Functional endoscopic sinus surgery Pulmonary Surgery Open and endoscopic pulmonary surgery (cutting, vaporization, incision and coagulation of soft tissue) General Surgery Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including: - · Appendectomy · Skin incision - · Excision of external and internal lesions - · Complete or partial resection of internal organs, turnors and lesions - · Biopsy
    Device Description
    The devices belonging to Holmium laser family are laser devices based on a Holmium laser source. The main parts (subsystems) of the device are the Holmium laser source, the power electronics, the optical delivery system, the control electronics and the cooling system. Specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.
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