510(k) Report

510(k) · Cleared

Cleared

Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber Green TM

K090962510(k) TraditionalCleared Jun 19, 200974-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2010: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2025: 2 descendants cleared2020: 1 descendant cleared2026: 1 descendant clearedK062719 · Greenlight HPS Series Surgical Laser System & Accessories · Laserscope · 2006 · recalled20052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants K062719 · Greenlight HPS Series Surgical Laser System & Accessories · Laserscope · 2006 · recalled0
  1. Root · 1 generation backK062719 Greenlight HPS Series Surgical Laser System & AccessoriesLaserscope · 2006 · Recalled
  2. This deviceK090962 Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber…Quanta System Spa · 2009
  3. Descendant · cites it directly · 7 of its ownK102749 Quanta Cyber TM 150WQuanta System Spa · 2010
  4. Descendant · 2 generations on · 3 of its ownK133891 Multipulse TM+1470Asclepion Laser Technologies GmbH · 2015
  5. Descendant · cites it directly · 2 of its ownK131081 Cyber TM FamilyQuanta System Spa · 2013
  6. Descendant · 3 generations on · 1 of its ownK253100 MultiPulse TFLAsclepion Laser Technologies GmbH · 2025
  7. 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

2010: 12013: 12015: 12017: 12020: 12025: 22026: 1
2010high 2 (2025) · low 0 (2011)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
−1K062719Greenlight HPS Series Surgical Laser System & AccessoriesLaserscope20065
0 (this device)K090962Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber Green TMQuanta System Spa2009—
+1K102749Quanta Cyber TM 150WQuanta System Spa2010—
+2K133891Multipulse TM+1470Asclepion Laser Technologies GmbH2015—
+1K131081Cyber TM FamilyQuanta System Spa2013—
+3K253100MultiPulse TFLAsclepion Laser Technologies GmbH2025—
+2K162334U.S. Laser Worx Patriot 1 family of lasersU.S. Laser Worx2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
201510
201710
202010
202520
202610
FIG. 1 — Lineage of K090962, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K070476Revolix 120
Summary 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…
Allmed Systems, Inc.2007—
*K062719Greenlight HPS Series Surgical Laser System & Accessories
Summary 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…
Laserscope20065

Also cleared against K070476: 3 other devices →

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102749Quanta Cyber TM 150WQuanta System Spa20107
K131081Cyber TM FamilyQuanta System Spa20132

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K102749 (Quanta System Spa, 2010) has gone furthest, with 7 descendants of its own.
  • 3 other devices also cite its predicate K070476.

How does its category compare?

All GEX devices

GEX 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

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

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.

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