# K102749: Quanta Cyber TM 150W

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Dec 10, 2010 after 78 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: 2 generations back to K062719 (2006). 3 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090962: Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber Green TM, Quanta System Spa (2009) Summary page 1.

## Most influential descendants
- K133891: Multipulse TM+1470 (2015), 3 descendants of its own
- K131081: Cyber TM Family (2013), 2 descendants of its own
- K253100: MultiPulse TFL (2025), 1 descendant of its own
- K162334: U.S. Laser Worx Patriot 1 family of lasers (2017), 1 descendant of its own
- K261738: Medical Thulium Fiber Laser Systems (UroFiber 150Q) (2026), 0 descendants of its own

## Indications for use
The Cyber Tmn 150W 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, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery.and Arthroscopy 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) - Laser Resection of the Prostrate (HoLRP) - Laser Enuculeation of the Prostate (HoLEP) - Laser Ablation of the Prostate (HoLAP) - Condylomas - Lesions of external genitalia 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 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, ablation 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 and laryngeal - Tonsillectomy - Adenoidectomy 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 Nephirectomy - 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 DecompressionlDiscectomy - Foraminoplasty - Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery.

Source page: https://510kreport.com/device/K102749
Methodology: https://510kreport.com/methodology