510(k) · Cleared
ClearedQuanta Cyber TM 150W
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 Dec 10, 2010 as substantially equivalent to K090962 (Quanta System Spa, 2009) after a 78-day review. Its family tree reaches back 2 generations to 2006. 7 later devices descend from it.
- Decided
- Dec 10, 2010
- Review
- 78 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K062719 (2006). 3 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK062719 Greenlight HPS Series Surgical Laser System & AccessoriesLaserscope · 2006 · Recalled
- 1 generation backK090962 Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber…Quanta System Spa · 2009
- This deviceK102749 Quanta Cyber TM 150WQuanta System Spa · 2010
- Descendant · cites it directly · 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 · 2 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
- Descendant · 2 generations on · 0 of its ownK261738 Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K133891Multipulse TM+1470Asclepion Laser Technologies GmbH · 2015 · cites it directly3descendants
- K131081Cyber TM FamilyQuanta System Spa · 2013 · cites it directly2descendants
- K253100MultiPulse TFLAsclepion Laser Technologies GmbH · 2025 · 2 generations on1descendant
- K162334U.S. Laser Worx Patriot 1 family of lasersU.S. Laser Worx · 2017 · 2 generations on1descendant
- K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K062719 | Greenlight HPS Series Surgical Laser System & Accessories | Laserscope | 2006 | 5 |
| −1 | K090962 | Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber Green TM | Quanta System Spa | 2009 | — |
| 0 (this device) | K102749 | Quanta Cyber TM 150W | Quanta System Spa | 2010 | — |
| +1 | K133891 | Multipulse TM+1470 | Asclepion Laser Technologies GmbH | 2015 | — |
| +1 | K131081 | Cyber TM Family | Quanta System Spa | 2013 | — |
| +2 | K253100 | MultiPulse TFL | Asclepion Laser Technologies GmbH | 2025 | — |
| +2 | K162334 | U.S. Laser Worx Patriot 1 family of lasers | U.S. Laser Worx | 2017 | — |
| +2 | K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | 2026 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K090962 | Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber Green TMSummary page 1…gy Classification Name: Instrument, surgical, powered, laser Predicate Devices: - Quanta System Cyber Surgical Laser Family (K090962); Intended Use /2.0 lum Applications: Indications for Use: The Cyber Tm 150W and its fiber opt… | 2009 |
What descends from it? (7)
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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K133891 (Asclepion Laser Technologies GmbH, 2015) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K090962.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Cyber Tmn 150W 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 hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery.and Arthroscopy Urology Open and endoscopic surgery (incision…
Read the full statement (457 words)
The Cyber Tmn 150W 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 hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, 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 (BHP),
- Transurethral incision of the prostate (TUIP)
- Laser Resection of the Prostrate (HoLRP)
- Laser Enuculeation of the Prostate (HoLEP)
- Laser Ablation of the Prostate (HoLAP)
- Condylomas
- Lesions of external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy
- Polyps
- Biopsy
- 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-Renu 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
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including:
- Endonasal/sinus Surgery
- Partial turbinectomy
- Polypectomy
- Dacryocystorhinostomy
- Frontal Sinusotomy
- Ethmoidectomy
- Maxillary antrostomy
- Functional endoscopic sinus surgery
- Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal
- Tonsillectomy
- Adenoidectomy
General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Cholecystectomy
- Lysis of adhesion
- Appendectomy
- Biopsy
- Skin incision
- Tissue dissection
- Excision of external tumors and lesions
- Complete or partial resection of internal organs, tumors and lesions
- Mastectomy
- Hepatectomy
- Pancreatectomy
- Splenectomy
- Thyroidectomy
- Parathyroidectomy
- Herniorrhaphy
- Tonsillectomy
- Lymphadenectomy
- Partial Nephirectomy
- Pilonidal. Cystectomy
- Resection of lipoma
- Debridement of Decubitus Ulcer
- Hemorrhoids
- Debridement of Statis Ulcer
- Biopsy
Arthroscopy
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 DecompressionlDiscectomy
- 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/K102749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102749: Quanta Cyber TM 150W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102749
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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