510(k) · Cleared
ClearedCyber TM Family
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 Jul 3, 2013 as substantially equivalent to K090962 (Quanta System Spa, 2009) and 2 other predicates after a 76-day review. Its family tree reaches back 3 generations to 2006. 2 later devices descend from it.
- Decided
- Jul 3, 2013
- Review
- 76 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K062719 (2006). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK062719 Greenlight HPS Series Surgical Laser System & AccessoriesLaserscope · 2006 · Recalled
- 2 generations backK090962 Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber…Quanta System Spa · 2009
- 1 generation backK102749 Quanta Cyber TM 150WQuanta System Spa · 2010
- This deviceK131081 Cyber TM FamilyQuanta System Spa · 2013
- Descendant · cites it directly · 1 of its ownK162334 U.S. Laser Worx Patriot 1 family of lasersU.S. Laser Worx · 2017
- Descendant · 2 generations on · 0 of its ownK251824 Patriot DuoPatriot Laser, LLC · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K062719 | Greenlight HPS Series Surgical Laser System & Accessories | Laserscope | 2006 | 5 |
| −2 | 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 | — |
| 0 (this device) | K131081 | Cyber TM Family | Quanta System Spa | 2013 | — |
| +1 | K162334 | U.S. Laser Worx Patriot 1 family of lasers | U.S. Laser Worx | 2017 | — |
| +2 | K251824 | Patriot Duo | Patriot Laser, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 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? (3)
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…eted Device The Cyber Tm Family is claimed to be substantially equivalent to these legally marketed devices: - Cyber Tmn 120 of the Cyber Surgical Laser Family (K090962) - Quanta System SpA - Cyber Tmn 150 (K1 02749) - Quanta System SpA - RevoLix Family (K1 10941) - AlMed System… | 2009 |
| * | K102749 | Quanta Cyber TM 150WSummary page 1…ntially equivalent to these legally marketed devices: - Cyber Tmn 120 of the Cyber Surgical Laser Family (K090962) - Quanta System SpA - Cyber Tmn 150 (K1 02749) - Quanta System SpA - RevoLix Family (K1 10941) - AlMed System Inc. Performance Standards: There are no mandatory pe… | 2010 |
| * | K110941 | Revolix JR 30, Revolix JR 50, Revolix JR 160, Revolix FR 200Summary page 1…- Cyber Tmn 120 of the Cyber Surgical Laser Family (K090962) - Quanta System SpA - Cyber Tmn 150 (K1 02749) - Quanta System SpA - RevoLix Family (K1 10941) - AlMed System Inc. Performance Standards: There are no mandatory performance standards for this device.… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162334 | U.S. Laser Worx Patriot 1 family of lasers | 2017 | 1 |
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 7 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K162334 (U.S. Laser Worx, 2017) has gone furthest, with 1 descendant 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. 2013, 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 Crewr TmnPamly (that Includes Cybor Tmn120, Cyber Tm 150, Cybor Tmn130 and Cyber Tmn230) and it8ccessories Ore Intended for meoin surgical procedures using open, laparoscopic and endoscoplo; incision, excision. reslection, ablation, vaporization. coagulation and hemostasis of soft tnssu in noe in medical specialties Including: Urology. Gstroenterology, Thoracic and Pulmonary. Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Open and…
Read the full statement (513 words)
The Crewr TmnPamly (that Includes Cybor Tmn120, Cyber Tm 150, Cybor Tmn130 and Cyber Tmn230) and it8ccessories Ore Intended for meoin surgical procedures using open, laparoscopic and endoscoplo; incision, excision. reslection, ablation, vaporization. coagulation and hemostasis of soft tnssu in noe in medical specialties Including: Urology. Gstroenterology, Thoracic and Pulmonary. Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and
Open and endloscopic surgery (incision, axebion. resection. ablation, vaporization, coagulation and hmosteals including:
-Urethral Strictures
*Bladder Neck Incisions (8141)
- Ablation and resection of Bladder Tumors, Uroihoral Tumors and Ureteral Tumors.
-Ablation of Benign Prostati; Hypertrophy, (SHP).
- Trensurebral incision of the prostate (TUIP)
*Laser Resecton of the Prostrate
- Loser Enucleator, of tM Prostate
-Laser Ablation ofthe Prostate
- Condylonmas
- Lesions of external genitalia
180 and Cyber Tmn200 are only approved for the treatment of BPH when used at power levels greater than 150W.
Open and endlostopic; gastroenterology surgery (incsion, exclsion, resoction, ablation, vaporintion, coagulti~on and hemostasis) including:
* Appendectomy
- Polyps
* Biopsy
- Gell Bladder calcull
. Biliary/Ble duct calculi
- Ulcers
- Gasti ulcers
- Duodenal ulcers
- Non Bleeding Ulcer,
* Pancrealitu.
- Hemorrhoids
- Cholecyslactoniy
* Benign and Malignant Neoplasm
* Angiodysplasia
- Colorectal caner
. Telanglectasias
- Telanglactaslas of the Osler-Weboor-Renu disease
- Vascular Malformation
-Gostrilis
-Esophogills
- Esophagel ulcers
-Varices
-Colitis
- Mallory-Weiss tear
-Gastrc Erosions
Open and taparoscopic, gynecological surgery (incision, excision, resection. ablation, vaporization. coagulation and hemnostass):
-Intr-uterine ashsonant of subnmucous fibroids
*bengn endornaetia polyps; and uterine sptumn by incision. excision. ablation and or vessel coagulation
- Soft tissue excision procedures such as excisional conkzatiou, of the corrix
Endoecopic endlonasal surgery (incision, excision, reseaction, ablation, vaporization, coagulation and hemnoslasis of soft lissue) IncludIng:
- Endlonasalisinus Surgery
* Partial turbbnectomy
* Polypectony
- Dacryocysbrhtnostomy
- Frontial Sinusotomny
- Ettunoidectomny
* Maxiltary anfrostomy
- Functional andloscopic sinus surgery
- Lesions or turmors of fiveoral, nasal, giossl, Pharyngeal end laryngeal
- Tonsillectomy
- Adenoidectonmy
Dennatolopy and Plastic Surery
Incision, excision, resection, ablation, vaporization, coagulation and hemnostasisol soft, mucosal fatty and cartilaginous tissue, In therapeutic plastic. deminatologic end aesti surgical procedures including:
*Basal Coil Carcinomoas
- Lesion of skin and subcutaneous tissue
*Skin tags
- planter warts
Open laparoscopic and endocopic surgery (Incision, excision, resection, ablation, vaporizaton, coagulation and henmostisis) Including:
-Cholecystactomy
-Lysis of adhesion
-Appendectomy
-Blopsy
-Skin incision
-Tissue dissectjon
-Excision of external tumors and lesions
-Complete or partial resection of Internet organs, tumors and lesion.
*Mastectomy
*Hepatectomy
*Pencrestectomy
-Splenectorny
*Thyroldectonly
-Pamliiyroidectomny
-Hemnlorrhaphy
*Toinsillectomy
-Lymphadonectomny
-Partial Nophroctomy
*Pflonidal Cystectomy
*Resection of lipome
-Debridenment of Decubritus Ulcer
- Hemorrhids
-Debridomont of Stals Ulcer
Thoracic and Pulmonary
Open and endtoscopio thoracic and pulmonary surgery (Incision. ecIsbn, resection. ablation, vaporization, coagulation and hernoslosis) of soft lissue
* Laryngeal lesions
*Airway obstructions Including carcinoma
* Polyp. and granuloma
*Palliation of obstructing carcinoma of ftet'aoheobroncisl tree
AnthrosoopyiOrthopedic surgery (eacisioi. ablation and coagulation of soft and cartlaginus tisse):
* Ablation of soft and cartlailmouw tissue in Mramai invashve spinal Surgepr including
- Peroitacct Laser DISC Decompressiofliscactomny
- Foraminoplasty
- Ablation and ccagulator of sof vascular- and nn vascular tiss inminimally lnvaaive spnal surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131081: Cyber TM Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131081
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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