# K060326: Lasertx - Diode Laser & Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Prosurg, Inc.
- Decided: Apr 5, 2006 after 55 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 K032864 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032864: Ceralas D 810 Diode Laser System, Model D15, Biolitec, Inc. (2004) Summary page 3.

## Indications for use
The LaserTx Diode Laser System is intended for delivery of laser light to soft tissue in contact or non contact mode during surgical procedures, including via endoscopes, introducers, or cathetrs. The LaserTx laser system is generally indicated for incision, excision Vaporization, ablation, henostatis or coagulation of soft tissue in Ear, Noew and Throat and Oral surgery (Otolaryngology), Dental Procedures, Arthroscopy Gastroenterology, General Surgery, Dermatology Plastic surgery, Podiatry, Urology, Gynecology, Neurosurgery (Peripheral nervous system) Pulmonary surgery and cardiothoracic surgery. The LaserTx Diode laser system can be used with fiber optic laser delivery devices and photosensitizing agents & chromophores to enabace target tissue effects and photo selective application during surgical procedures. The LaserTx Diode Laser system is indicated for incision, excision, vaporization, bemostatis coagulation, ablation of soft tissue, tumors, strictures, obstructions in body organs including urethra, bladder, prostate, uterus, breast, stomach, colon, abdomen, veins ling, brain. ear, nose throat etc. For additional indications for use please refer to attachment. (Additional Indications, identical to predicated device cleared by FDA under 510K application f K032864) The device is specifically indicated for use as follows: Ear, Nose and Throat and Oral Sirnewy (Otolaryn.9ologY) Heinostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, vose, throat and adjacent areas including soft tissue in the oral cavity. Examples include: • Removal of benign lesions forom the ear, nose and throat • Excision and vaporization of vocal cord nodules and polyps • Incision and excision of carcinoma in situ • Ablation and vaporization of hyperkeratosis • Excision of carcinoma of the larynx • Laryngeal papillomertoiny • Excision and vaporization of herpes simplex I and II • Neck dissection Arthroscopy Ijenostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthrosmopic surgery. Examples inchude: • Mertisectomy • Synoveactomy • Chondromalacia Gastroenterology, Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and. lower gastrointestinal tracts. and also with endoscapic procedures. Examples include: • Hemostasis of upper and lower GI bleeding- • Excision and vaporization of7 colorectal caip6n~ • Excision of polyps Genera] Surgery, Dermatology, Plastic Surgery and Podiatry Excision, ablation, vaporization and photocoagulationaof skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectaL, skin, fat or muscle tissue and dermabrasion. Examples include: Matrixectoiny •Excision of neuromas •Excision of periurngual and subungual warts •Excision of plantar warts •Excision of Iceloids • Uver resection • Excision of cutaneous lesions • lHemorrhoidectomy • AppendectomY • Debridemnent of decubitus ulcers • Hepatobiliary tumors • Mastectomny • Dermabrasian • Vaporization and horneostasis of capillary hemnangioma • Excision, vaporization and hemostasis of abdominal tumors • Excision, vaporization and hemlOstasis of rectal pathology • Pilonidal cystectomy • Herniorapphw • Adhesiolysis • Parathyzoidectorny • Laparoscopic cholecystectomy • Thyroidectomy • Resection of organs • Debridemenat of wounds • Fhototcaagulation 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 horneosqtasis of urolagical tissues. Examples include: • Vaporization of urethral tumors • Release of urethral stricture • Removal of bladder neck obstruction • Excision and vaporization of condyloma • Lesions of external genitalia Gynecology Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue, Examples include: • Endometrial ablation • Excision or vaporization of condylomata acuminata • Vaporization of cervical intraepithelial ncaplasia • Cervical conization • Menorrhagia Neurosurgery Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: homeostasis in conjunction with menigiomas Cardiac Surgery Hemostasis and coagulation of soft tssue, including cardiac tissue. Pulmonary Surgery HFemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include: Tracheobroachial 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, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous 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 with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Source page: https://510kreport.com/device/K060326
Methodology: https://510kreport.com/methodology