# K090962: Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber Green TM

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Jun 19, 2009 after 74 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: 1 generation back to K062719 (2006). 2 ancestors in all.
8 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)
- K070476: Revolix 120, Allmed Systems, Inc. (2007) Summary page 1.
- K062719: Greenlight HPS Series Surgical Laser System & Accessories, Laserscope (2006) Summary page 1.

## Most influential descendants
- K102749: Quanta Cyber TM 150W (2010), 7 descendants of its own
- 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

## Indications for use
532nm Applications: The Cyber Surgical Laser Family and Accessories are intended for the surgical incision/excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. General Surgery: Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft tissue as well as in Endoscopic (e.g. laparoscopic) or open surgeries. Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal hemostasis (including Varices, Espohagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulcers, Non-bleeding Ulcers, Gastric erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids). Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: Endometriosis; Cervical, vulvar, and vaginal intraepitheal neoplasia; Condyloma Acuminata; Uterine Septum; Intrauterine adhesions; Submucosal fibroids. Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis. Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type. Opthamology: Post-vitrectomy endophotocoagulation of the retina. Plastic Surgery: Vaporizing, Coagulating, Incising, Excising, debulking, and ablating of soft tissue in endoscopic and open procedures. Spinal Surgery: Percutaneous lumbar diskectomy. Thoracic Surgery: Vaporizing, Coagulating, Iniig, Excising, Debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures. Urology: Cutting, coagulating, or vaporizing urologic soft tissues..Open endoscopic minimally invasive urological. surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: Bladder; Urethral & Ureteral Tumors; Condylomas; Lesions of external genitalia; Urethral & penile Hemangioma; Urethral Strictures; Bladder Neck Obstructions; and, when used at 532nm it is intended to hemostatically vaporize prostate tissue of men suffering from benign prostate hyperplasia/hypoplasia (BPH). The device is not intended to treat prostate cancer. 2. 0 1 M Applications: The Cyber Surgical Laser Family 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 hernostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, 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 (Bill), - Transurethral incision of the prostate (TUIP) - Laser Resection of the Prostrate (HoLRP) - Laser Enuculeation of the Prostate (HoLEP) - Laser Ablation of the Prostate (HoLAP) - Condylonmas. - Lesions of external genitalia Gastroenterology Open and endoscopic gastroenterology surgery (incision, excsoretinabto, vaporization, coagulation and hemostasis) including: - Aolppedctm - BiPolpsy - 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-R-enu 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 Endloscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasi8 of soft tissue) including: - Endonasal/sinus Surgery - Partial turbinectomy - Polypectomy - Dacryocystorhimostomy - Frontal Sinusotomy - Ethmoidectomy - Maxillary antrostomy - Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal Tonsillectomy Adenoidectomy General Surnqgery Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Arthrbscopy Cholecystectomy Liysis of adhesion Appendectomy Biopsy Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, twmors and legions 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/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 Decompresswn/Dlscectomy Foraminoplasty - Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery.

Source page: https://510kreport.com/device/K090962
Methodology: https://510kreport.com/methodology