510(k) · Cleared
ClearedCyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber Green TM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quanta System Spa · GEX Powered Laser Surgical Instrument
Cleared on Jun 19, 2009 as substantially equivalent to K070476 (Allmed Systems, Inc., 2007) and 1 other predicate after a 74-day review. Its family tree reaches back 1 generation to 2006. 8 later devices descend from it.
- Decided
- Jun 19, 2009
- Review
- 74 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K062719 (2006). 2 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK062719 Greenlight HPS Series Surgical Laser System & AccessoriesLaserscope · 2006 · Recalled
- This deviceK090962 Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber…Quanta System Spa · 2009
- Descendant · cites it directly · 7 of its ownK102749 Quanta Cyber TM 150WQuanta System Spa · 2010
- Descendant · 2 generations on · 3 of its ownK133891 Multipulse TM+1470Asclepion Laser Technologies GmbH · 2015
- Descendant · cites it directly · 2 of its ownK131081 Cyber TM FamilyQuanta System Spa · 2013
- Descendant · 3 generations on · 1 of its ownK253100 MultiPulse TFLAsclepion Laser Technologies GmbH · 2025
- Descendant · 2 generations on · 1 of its ownK162334 U.S. Laser Worx Patriot 1 family of lasersU.S. Laser Worx · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K102749Quanta Cyber TM 150WQuanta System Spa · 2010 · cites it directly7descendants
- K133891Multipulse TM+1470Asclepion Laser Technologies GmbH · 2015 · 2 generations on3descendants
- K131081Cyber TM FamilyQuanta System Spa · 2013 · cites it directly2descendants
- K253100MultiPulse TFLAsclepion Laser Technologies GmbH · 2025 · 3 generations on1descendant
- K162334U.S. Laser Worx Patriot 1 family of lasersU.S. Laser Worx · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062719 | Greenlight HPS Series Surgical Laser System & Accessories | Laserscope | 2006 | 5 |
| 0 (this device) | K090962 | Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber Green TM | Quanta System Spa | 2009 | — |
| +1 | K102749 | Quanta Cyber TM 150W | Quanta System Spa | 2010 | — |
| +2 | K133891 | Multipulse TM+1470 | Asclepion Laser Technologies GmbH | 2015 | — |
| +1 | K131081 | Cyber TM Family | Quanta System Spa | 2013 | — |
| +3 | K253100 | MultiPulse TFL | Asclepion Laser Technologies GmbH | 2025 | — |
| +2 | K162334 | U.S. Laser Worx Patriot 1 family of lasers | U.S. Laser Worx | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070476 | Revolix 120Summary page 1…rmatology Classification Name: Instrument, surgical, powered, laser Predicate Devices: - AliMed System Revolix 120 Laser System (K070476); - Laserscope GreenLight HPS Series Surgical Laser and System Accessorie… | 2007 |
| * | K062719 | Greenlight HPS Series Surgical Laser System & AccessoriesSummary page 1…(K070476); - Laserscope GreenLight HPS Series Surgical Laser and System Accessories (K062719); Intended Use I 532nm Applications: Indications for Use: The Cyber Surgical Laser Family and Ac… | 2006 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
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?
532nm Applications: The Cyber Surgical Laser Family and Accessories are intended for the surgical incision/excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. General Surgery: Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating…
Read the full statement (719 words)
532nm Applications:
The Cyber Surgical Laser Family and Accessories are intended for the surgical incision/excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
General Surgery:
Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft tissue as well as in Endoscopic (e.g. laparoscopic) or open surgeries.
Gastroenterology:
Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma;
Gastrointestinal hemostasis (including Varices, Espohagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulcers, Non-bleeding Ulcers, Gastric erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids).
Gynecology:
Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: Endometriosis; Cervical, vulvar, and vaginal intraepitheal neoplasia; Condyloma Acuminata; Uterine Septum; Intrauterine adhesions; Submucosal fibroids.
Head and Neck/Otorhinolaryngology (ENT):
Tissue incision, excision, ablation, and vessel hemostasis.
Neurosurgery:
Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.
Opthamology:
Post-vitrectomy endophotocoagulation of the retina.
Plastic Surgery:
Vaporizing, Coagulating, Incising, Excising, debulking, and ablating of soft tissue in endoscopic and open procedures.
Spinal Surgery:
Percutaneous lumbar diskectomy. Thoracic Surgery: Vaporizing, Coagulating, Iniig, Excising, Debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.
Urology:
Cutting, coagulating, or vaporizing urologic soft tissues..Open endoscopic minimally invasive urological. surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: Bladder; Urethral & Ureteral Tumors; Condylomas; Lesions of external genitalia; Urethral & penile Hemangioma; Urethral Strictures; Bladder Neck Obstructions; and, when used at 532nm it is intended to hemostatically vaporize prostate tissue of men suffering from benign prostate hyperplasia/hypoplasia (BPH). The device is not intended to treat prostate cancer.
2. 0 1 M Applications:
The Cyber Surgical Laser Family and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hernostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, General Surgery, and Arthroscopy
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Urethral Strictures
- Bladder Neck Incisions (BNI)
- Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors.
- Ablation of Benign Prostatic Hypertrophy (Bill),
- Transurethral incision of the prostate (TUIP)
- Laser Resection of the Prostrate (HoLRP)
- Laser Enuculeation of the Prostate (HoLEP)
- Laser Ablation of the Prostate (HoLAP)
- Condylonmas.
- Lesions of external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excsoretinabto, vaporization, coagulation and hemostasis) including:
- Aolppedctm
- BiPolpsy
- Gall Bladder calculi
- Biliary/Bile duct calculi
- Ulcers
- Gastric ulcers
- Duodenal ulcers
- Non Bleeding Ulcers
- Pancreatitas
- Hemorrhoids
- Cholecystectomy
- Benign and Malignant Neoplasm.
- Angiodysplasia
- Colorectal cancer
- Telangiectasias
- Telangiectasias of the Osler-Weber-R-enu disease
- Vascular Malformation
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weiss tear
- Gastric Erosions
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis)
- Intra-uterine treatment of submucous fibroids, benign endometrial polyps,
- and uterine septum by incision, excision, ablation and or vessel coagulation
- Soft tissue excision procedures such as excisional conization of the cervix
ENT
Endloscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasi8 of soft tissue) including:
- Endonasal/sinus Surgery
- Partial turbinectomy
- Polypectomy
- Dacryocystorhimostomy
- Frontal Sinusotomy
- Ethmoidectomy
- Maxillary antrostomy
- Functional endoscopic sinus surgery
Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal
Tonsillectomy
Adenoidectomy
General Surnqgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Arthrbscopy
Cholecystectomy
Liysis of adhesion
Appendectomy
Biopsy
Skin incision
Tissue dissection
Excision of external tumors and lesions
Complete or partial resection of internal organs, twmors and legions
Mastectomy
Hepatectomy
Pancreatectomy
Splenectomy
Thyroidectomy
Parathyroidectomy
Herniorrhaphy
Tonsillectomy
Lymphadenectomy
Partial Nephrectomy
Pilonidal Cystectomy
Resection of lipoma
Debridement of Decubitus Ulcer
Hemorrhoids
Debridement of Statis Ulcer
Biopsy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)
Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including
Percutaneous Laser Disc Decompresswn/Dlscectomy
Foraminoplasty
- Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K090962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090962: Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber Green TM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090962
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026