# K132975: Sphinx JR

- Pathway: 510(k) (Traditional)
- Applicant: Allmed Systems, Inc.
- Decided: Mar 18, 2014 after 176 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
Longest line of descent: 6 generations back to K936109 (1994). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033437: Sphinx Laser Systems, Allmed Systems, Inc. (2004) Summary page 5.
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001) Summary page 5.

## Most influential descendants
- K211534: RevoLix HTL (2022), 0 descendants of its own

## Indications for use
The Sphinx Jr. laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis or' soft and hard tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroseopy, Discectomy, 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 Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hypertrophy (BHP) Resection of tbe Prostrate Condylomas Lesions of external genitalia Litbotripsy and Percutaneous Urinary Lithotripsy Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi Endoscopic firagmnentation of kidney calculi Treatment of steinstrasse when guide wire cannot be passed Gasteroenterlogy Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporiyzation, coagatilonnard hemostasis) including Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Pancreatitas Hemorrhoids Choiccystctomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangicctasias Vascular Malformation Gastritis Esophagitis Artliroscopy Arlhroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) 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 Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc DecompressioniDiscectorny Foraniinop lusty Pulmonary Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemoslasis) Gynecology Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Outer female genitals Ablation of condilomata and genital warts Inner genitalia Endometrium ablation Treatment of Uterine polyps Treatment of endometriosis ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hernosgasis oftsol tissue) including:. Endonasal/sinus Surgery Partial turbinectomy Polypectoiny Dacryocystorhinostomy Ethmoidectoniy 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 General Surgery Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemiostqsis) 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/K132975
Methodology: https://510kreport.com/methodology