Holmium Medical Laser

Allengers Global Healthcare Private Limited

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

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

4

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

4

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