# K090297: Blueshine Gold Series

- Pathway: 510(k) (Traditional)
- Applicant: Blueshine Srl
- Decided: Apr 14, 2009 after 67 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
980 rn Wavelengths The Blueshine GOLD series, (and the fiber delivery systems and accessories used to deliver laser energy), is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery. The Blueshine GOLD series Laser is indicated for use in the performance of specific surgical applications in gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery as follows: Gastroenterology The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include: hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis of colonoscopy. Neurosurgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include: tumors adjacent to the spinal cord; tumors adjacent to the cortex. General Surgery Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: Laparoscopic: appendectomy; cholecystectomy; bowel resection. Open: mastectomy; reduction mammoplasty; breast biopsy; rectal and anal hemorrhoidectomy; bowel resection; colectomy; cholecystectomy; liver resection; condyloma; thyroidectomy; thoracotomy; cavernous hemangioma. Genitourinary (Uroloyv) The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: Transurethral: transurethral incision of the prostate (TUIP); bladder tumors; bladder neck incisions; urethral strictures; exterior sphincterotomy. Laparoscopic lymphadenectomy. Open: condyloma; circumcision; benign and malignant lesions of external genitalia Thoracic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include: pulmonary resection; coagulation of blebs and bullae; adhesiolysis; pericardiectomy; mediastinal and thoracic lesions and abnormalities; mediastinal lymph node dissection; hemostasis; thoracotomy. Gvnecolorv (GYN) The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include: Laparoscopic excision/lysis of adhesions; endometrial lesions, including ablation of endometriosis; laparoscopic assisted hysterectomy (LAVH); laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy; ovarian drilling; tubal fimbrioplasty; appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN; condyloma acuiminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/polyps/adhesions; Resection of septum. Pulmonology The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions. Ophthalmologv The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: Oculoplastics; open DCR; endo-nasal DCR; tumor excision and biopsy; eyelid reconstruction; blepharoplasty. Orthopedics The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include: Open: Dissect and coagulate. Otolarvznolouv (ENT) The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: Nasal/Sinus: turbinectomy and turbinate reduction/ablation; polypectomy of nose and nasal passages; ethmoidectomy; meatal antrostomy; Laryngo-tracheal: removal of vocal cord/fold nodules, polyps and cysts;arytenoidectomy; tracheal stenosis; O0ropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsfllar cryptolysis, neoplasma) and tonsil; hemi glossectomy; Head & Neck: tumor resection on oral, subfacial and neck tissues; parathyroidectomy; thyroidectomy. In addition the Blueshine GOLD series Laser is intended for Laser Assisted Lipolysis

Source page: https://510kreport.com/device/K090297
Methodology: https://510kreport.com/methodology