Manufacturer
Allengers Global Healthcare Private LimitedHolmium Medical Laser
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
- K231718
- Device name
- Holmium Medical Laser
- Country / Region
- India(IN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-06-13
- Decision date
- 2023-08-18
- Submission type
- Traditional
- Technology type
- Holmium (Ho:YAG)(AI inferred)
- Clinical applications
- Surgical cuttingVascular treatmentOtherAcne treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Holmium Medical Laser and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynecology, ENT, Pulmonary Surgery and General Surgery. Urology Open and endoscopic surgery (incision, excision, 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 Prostate (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 urethral, 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, excision, 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 * Pancreatitis * 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-SI lumbar discs, including Foraminoplasty * Percutaneous Cervical Disc Decompression/Discectomy * Percutaneous Thoracic Disc Decompression/Discectomy Gynecology Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) of soft tissue. ENT Endoscopic endonasal surgery (incision, excision, resection, ablation,
Intended Use
The Holmium Medical Laser and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynecology, ENT, Pulmonary Surgery and General Surgery.
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.
Summary parsed at:2026-06-01 05:33:03 UTC
Predicate devices
4Litho
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
Empower H65
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
K231718 references 4 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K231718 as a predicate
