# K131081: Cyber TM Family

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Jul 3, 2013 after 76 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: 3 generations back to K062719 (2006). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 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.
- K102749: Quanta Cyber TM 150W, Quanta System Spa (2010) Summary page 1.
- K110941: Revolix JR 30, Revolix JR 50, Revolix JR 160, Revolix FR 200, Allmed Systems, Inc. (2013) Summary page 1.

## Most influential descendants
- K162334: U.S. Laser Worx Patriot 1 family of lasers (2017), 1 descendant of its own
- K251824: Patriot Duo (2025), 0 descendants of its own

## Indications for use
The Crewr TmnPamly (that Includes Cybor Tmn120, Cyber Tm 150, Cybor Tmn130 and Cyber Tmn230) and it8ccessories Ore Intended for meoin surgical procedures using open, laparoscopic and endoscoplo; incision, excision. reslection, ablation, vaporization. coagulation and hemostasis of soft tnssu in noe in medical specialties Including: Urology. Gstroenterology, Thoracic and Pulmonary. Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Open and endloscopic surgery (incision, axebion. resection. ablation, vaporization, coagulation and hmosteals including: -Urethral Strictures *Bladder Neck Incisions (8141) - Ablation and resection of Bladder Tumors, Uroihoral Tumors and Ureteral Tumors. -Ablation of Benign Prostati; Hypertrophy, (SHP). - Trensurebral incision of the prostate (TUIP) *Laser Resecton of the Prostrate - Loser Enucleator, of tM Prostate -Laser Ablation ofthe Prostate - Condylonmas - Lesions of external genitalia 180 and Cyber Tmn200 are only approved for the treatment of BPH when used at power levels greater than 150W. Open and endlostopic; gastroenterology surgery (incsion, exclsion, resoction, ablation, vaporintion, coagulti~on and hemostasis) including: * Appendectomy - Polyps * Biopsy - Gell Bladder calcull . Biliary/Ble duct calculi - Ulcers - Gasti ulcers - Duodenal ulcers - Non Bleeding Ulcer, * Pancrealitu. - Hemorrhoids - Cholecyslactoniy * Benign and Malignant Neoplasm * Angiodysplasia - Colorectal caner . Telanglectasias - Telanglactaslas of the Osler-Weboor-Renu disease - Vascular Malformation -Gostrilis -Esophogills - Esophagel ulcers -Varices -Colitis - Mallory-Weiss tear -Gastrc Erosions Open and taparoscopic, gynecological surgery (incision, excision, resection. ablation, vaporization. coagulation and hemnostass): -Intr-uterine ashsonant of subnmucous fibroids *bengn endornaetia polyps; and uterine sptumn by incision. excision. ablation and or vessel coagulation - Soft tissue excision procedures such as excisional conkzatiou, of the corrix Endoecopic endlonasal surgery (incision, excision, reseaction, ablation, vaporization, coagulation and hemnoslasis of soft lissue) IncludIng: - Endlonasalisinus Surgery * Partial turbbnectomy * Polypectony - Dacryocysbrhtnostomy - Frontial Sinusotomny - Ettunoidectomny * Maxiltary anfrostomy - Functional andloscopic sinus surgery - Lesions or turmors of fiveoral, nasal, giossl, Pharyngeal end laryngeal - Tonsillectomy - Adenoidectonmy Dennatolopy and Plastic Surery Incision, excision, resection, ablation, vaporization, coagulation and hemnostasisol soft, mucosal fatty and cartilaginous tissue, In therapeutic plastic. deminatologic end aesti surgical procedures including: *Basal Coil Carcinomoas - Lesion of skin and subcutaneous tissue *Skin tags - planter warts Open laparoscopic and endocopic surgery (Incision, excision, resection, ablation, vaporizaton, coagulation and henmostisis) Including: -Cholecystactomy -Lysis of adhesion -Appendectomy -Blopsy -Skin incision -Tissue dissectjon -Excision of external tumors and lesions -Complete or partial resection of Internet organs, tumors and lesion. *Mastectomy *Hepatectomy *Pencrestectomy -Splenectorny *Thyroldectonly -Pamliiyroidectomny -Hemnlorrhaphy *Toinsillectomy -Lymphadonectomny -Partial Nophroctomy *Pflonidal Cystectomy *Resection of lipome -Debridenment of Decubritus Ulcer - Hemorrhids -Debridomont of Stals Ulcer Thoracic and Pulmonary Open and endtoscopio thoracic and pulmonary surgery (Incision. ecIsbn, resection. ablation, vaporization, coagulation and hernoslosis) of soft lissue * Laryngeal lesions *Airway obstructions Including carcinoma * Polyp. and granuloma *Palliation of obstructing carcinoma of ftet'aoheobroncisl tree AnthrosoopyiOrthopedic surgery (eacisioi. ablation and coagulation of soft and cartlaginus tisse): * Ablation of soft and cartlailmouw tissue in Mramai invashve spinal Surgepr including - Peroitacct Laser DISC Decompressiofliscactomny - Foraminoplasty - Ablation and ccagulator of sof vascular- and nn vascular tiss inminimally lnvaaive spnal surgery.

Source page: https://510kreport.com/device/K131081
Methodology: https://510kreport.com/methodology