# K070466: Revolix Duo Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Allmed Systems, Inc.
- Decided: Apr 17, 2007 after 60 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lisa Laser Products - RevoLix Continous Wave 2 micron Laser: named in the summary without a submission number
- (no number) Lisa Laser Products - Sphinx 80 Watt Holmium Laser System: named in the summary without a submission number

## Indications for use
The Revolix Duo continuous wave 2.01 micron laser system 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 hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery Continuous Wave 2.01 micron Laser Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hyperplasia (BHP), Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enuculeation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia Gasteroenterlogy Open and endoscopic gasteroenterlogy surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids 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 Thoracic and Pulmonary Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue Laryngeal Lesions Airway obstructions including carcinoma Polyps and Granuloma Palliation of obstructing carcinoma of the tracheobroncial tree Gynecology Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision and or vessel coagulation Soft tissue excision procedures such as excisional conization of the cervix ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal or laryngeal Tonsillectomy Adenoidectomy Dermatology and Plastic Surgery Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft,mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts General Surgery Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Cholecystectomy Lysis of adhesion Appendectomy Biopsy Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomy Hepatectomy Pancreatectomy Splenectomy Thyroidectomy Parathyroidectomy Herniorrhaphy Tonsillectomy Lymphadenectomy Partial Nephrectomy Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer Biopsy Arthroscopy Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc Decompression/Discectomy Foraminoplasty Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery. The Revolix Duo pulsed Holmium 2.1 micron laser system 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 hemostasis of soft and hard tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery. Holmium Laser pulsed 2.1 micron Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enuculeation 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 hemostasis ) including: Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids 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/Orthopedic 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 inthe 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 Pulmonary Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) Gynecology Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Dermatology and Plastic Surgery Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas General Surgery Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete of partial resection of internal organs, tumors and lesions Biopsy

Source page: https://510kreport.com/device/K070466
Methodology: https://510kreport.com/methodology