# K033437: Sphinx Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Allmed Systems, Inc.
- Decided: Jan 20, 2004 after 84 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.
28 later devices descend from it; 5 cite it directly.
0 of 29 devices 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) Lumenis VersaPulse PowerSuite 100 watt Holmium Laser: named in the summary without a submission number
- (no number) Trimedyne OmniMax 80 watt Holmium Laser: named in the summary without a submission number

## Most influential descendants
- K091909: Litho Laser System (2009), 18 descendants of its own
- K141101: LITHO (2014), 14 descendants of its own
- K163009: Litho (2016), 12 descendants of its own
- K170331: Cyber Ho (2017), 9 descendants of its own
- K172025: Litho 60 (2017), 8 descendants of its own

## Indications for use
The Sphinx 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. 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 extemal genitalia Lithotrpsy 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. Gasteroenterlopy 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 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 Countouring and sculpting of articular surfaces Capsulectomy in the Knee Chondreplasty in the Knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacla 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 Dermatolocqy and Plastic Surmierr 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/K033437
Methodology: https://510kreport.com/methodology