# K082230: Vectra Plus Laser System and Accessories - Pathway: 510(k) (Traditional) - Applicant: Xintec Corporation - Decided: Feb 3, 2010 after 545 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: 17 generations back to K943450 (1995). 330 ancestors in all. 112 later devices descend from it; 1 cites it directly. 0 of 443 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K024088: Ceralas D 980 Laser System with Endo Laser Vein System Kit, Model: D15 and D25, Biolitec, Inc. (2003) Summary page 1. - K032863: Ceralas D 980 Diode Laser System, Models D15, D25, D50, Biolitec, Inc. (2004) Summary page 1. - K050824: 100W Ceralas D 980 Laser System, Model D100, Biolitec, Inc. (2005) Summary page 1. - K071295: 100W Ceralas D 980NM Diode Laser, Biolitec, Inc. (2007) Summary page 1. - K072106: 150W Ceralas D 980NM Diode Laser, Biolitec, Inc. (2007) Summary page 1. - K072682: 50W Ceralas D 1950NM Diode Laser, Biolitec, Inc. (2008) Summary page 1. - K073063: 15W Ceralas D 1470NM Diode Laser, Biolitec, Inc. (2008) Summary page 1. - K082225: 15W Ceralas D 1470NM Diode Laser, Model D1470, Biolitec, Inc. (2008). Cleared while this submission was under review Summary page 1. - K083682: 180W Cerelas D 980NM Diode Laser, Model D180, Biolitec, Inc. (2009). Cleared while this submission was under review Summary page 1. - K090164: Ceralas Multiwavelength 980/1470NM Diode Laser, Biolitec, Inc. (2009). Cleared while this submission was under review Summary page 1. - K060114: Vectra Laser System, Xintec Corporation, Dba, (2006) Summary page 1. - K902871: Optilite Fiberoptic Delivery Systems, Xintec Corporation (1990) Summary page 1. - K910114: Optilite (TM) Fiberoptic Delivery Systems and Acce, Xintec Corporation (1991) Summary page 1. - K923599: Optilite Fiberoptic Delivery Systems, Xintec Corporation (1993) Summary page 1. - K944474: Optilite V Fiberoptic Accessories, Xintec Corporation (1994) Summary page 1. - K944965: Optilite VI Fiberoptic Accessories, Xintec Corporation (1995) Summary page 1. - K944704: Optilite (TM) Vii Fiberoptic Accessories Rotalase (TM) Angle Delivery Systemsn and Accessories, Xintec Corporation (1995) Summary page 1. - K951760: Optilite Viii Laser Surgery Accessories, Xintec Corporation (1995) Summary page 1. - K992866: Optilite IX Laser Surgery Accessories, Convergent Laser Technologies (1999) Summary page 1. - K080121: Cynosure Smartlipo Multiwavlength Laser, Cynosure, Inc. (2008) Summary page 1. ## Most influential descendants - K101916: Joule Multi-Platform System (2011), 111 descendants of its own - K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own - K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own - K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own - K153671: Family of CoolGlide Aesthetic Lasers (2016), 32 descendants of its own ## Indications for use The device is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes. The device is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, genecology, neurosurgery (peripheral nervous system), pulmonary and cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein. The device is specifically indicated for use as follows: Ear, Nose and Throat and Oral Surgery (Otolaryngology) Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include: Removal of benign lesions from the ear, nose and throat, e.g., turbinectomy Excision and vaporization of vocal cord nodules & polyps, e.g., tonselectomy, uvelaplasty Incision and excision of carcinoma in situ, e.g., bronchoscopy Ablation and vaporization of hyperkeratosis Excision of carcinoma of the larynx Laryngeal papillomectomy Excision and vaporization of herpes simplex I and H1 Neck dissection Arthroscopy Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include: Menisectomy Synovectomy Chondromalacia Gastroenterology Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: Hemostasis of upper and lower GI bleeding Excision and vaporization of colorectal carcinoma Excision of polyps General Surgery, Dermatology, Plastic Surgery and Podiatry Excision, ablation, vaporization and photocoagulation of skin lesions, hemnostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion, Examples include: Matrixectomny Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts and keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcers Hepatobiliary tumors Mastectomy Dermabrasion Vaporization and hemostasis of capillary hemangioma Excision, vaporization and hemnostasis of abdominal tumors Excision, vaporization and hemostasis of rectal pathology Pilonidal cystectomy Hemiorapphy Adhesiolysis Parathyroidectomny Laparoscopic cholecystectomay Thyroidectomy Resection of organs Debridemnent of wounds Photocoagulation of teleangectasia of the legs and face Photocoagulation of vascular lesions of the face and extremities Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux Treatment of reticular veins and branch varicosities Urology Excision, vaporization, incision, coagulation, ablation and hemostasis of urological, including BPHlprostatic, tissues. Examples include: Vaporization of uretheral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia Vaporization of the prostate to treat benign prostatic hyperplasia (BPH) Gynecology Ablation, excision, incision, coagulation, hemostasis and vaporization of gynechological tissue. Examples include: Endometrial ablation Excision or vaporization of condylomata aCLuminata Vaporization of cervical intraepithelial neoplasia Cervical conization Menorrhagia Neurosurgery Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue Examples include: Hemeostasis in conjunction with menigiomnas Cardiac Surgery Hemnostasis and coagulation of soft tissue, including cardiac tissue Pulmonary Surgery H'emostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction Endoscopic pulmonary applications Dental Applications Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aplithous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening. Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux Indicated for use in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux associated with varicose veins and varicosities Source page: https://510kreport.com/device/K082230 Methodology: https://510kreport.com/methodology