510(k) · Cleared
ClearedBlueshine Gold Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blueshine Srl · GEX Powered Laser Surgical Instrument
Cleared on Apr 14, 2009 after a 67-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 14, 2009
- Review
- 67 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (540 words)
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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K090297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090297: Blueshine Gold Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090297
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026