510(k) · Cleared
ClearedDiode Medical Laser Family, Models 4, 6, 30
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 Sep 20, 2007 as substantially equivalent to K042211 (Surgical Laser Technologies, Inc., 2004) and 4 other predicates after a 57-day review. Its family tree reaches back 14 generations to 1995. 263 later devices descend from it.
- Decided
- Sep 20, 2007
- Review
- 57 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K943450 (1995). 169 ancestors in all, the oldest K800617 (1980). 263 later devices descend from it, 7 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 1 generation backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- This deviceK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- Descendant · cites it directly · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- Descendant · cites it directly · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- Descendant · 4 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 1 generation backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- This deviceK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
Showing 5 of 263 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 263 · See all- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · cites it directly192descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
- K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · cites it directly68descendants
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 4 generations on62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −6 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −3 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −2 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −1 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| 0 (this device) | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| +1 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +3 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| +1 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| +4 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 12 | 0 |
| 1996 | 15 | 0 |
| 1997 | 18 | 0 |
| 1998 | 9 | 0 |
| 1999 | 6 | 0 |
| 2000 | 13 | 0 |
| 2001 | 13 | 0 |
| 2002 | 17 | 0 |
| 2003 | 13 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 7 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 10 | 0 |
| 2014 | 9 | 0 |
| 2015 | 13 | 0 |
| 2016 | 11 | 0 |
| 2017 | 10 | 0 |
| 2018 | 13 | 0 |
| 2019 | 9 | 0 |
| 2020 | 19 | 0 |
| 2021 | 12 | 0 |
| 2022 | 24 | 0 |
| 2023 | 17 | 0 |
| 2024 | 28 | 0 |
| 2025 | 43 | 0 |
| 2026 | 21 | 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? (5)
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 |
|---|---|---|---|
| * | K042211 | Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSummary page 1…GEX 21 C.F.R. 878.4810 Predicate Devices: PhotoMedex, Inc.'s LaserPro Surgical Diode Laser System (K04221 1) *Diomed, Inc. EVLT Kit and DPlus Lasers (K04 1957)… | 2004 |
| * | K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode LasersSummary page 1…o Surgical Diode Laser System (K04221 1) *Diomed, Inc. EVLT Kit and DPlus Lasers (K04 1957) *BioLase Technology, Inc EZLase Dental Diode Laser system (K06 1898)… | 2004 |
| * | K061898 | EzlaseSummary page 1…Plus Lasers (K04 1957) *BioLase Technology, Inc EZLase Dental Diode Laser system (K06 1898) *INTERmiedic Arfran, S.A. INTERinedic Diode Laser Family (K053540)… | 2007 |
| * | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Summary page 1…Laser system (K06 1898) *INTERmiedic Arfran, S.A. INTERinedic Diode Laser Family (K053540) *Dornier MedTech America, Inc Dornier Diode Laser Family (K020339) In… | 2006 |
| * | K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Summary page 1…Laser Family (K053540) *Dornier MedTech America, Inc Dornier Diode Laser Family (K020339) Intended Use/ 808 rim, 940 nm, 980nm Wavelengths Indications for Use: The Quanta System Diode Medical Lasers Family,… | 2002 |
What descends from it? (263)
See all 2637 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083613 | Quanta System Polysurge Diode Laser Family | 2008 | 192 |
| K100558 | Quanta Diode Laser System | 2010 | 68 |
| K100726 | Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode… | 2010 | 54 |
| K090762 | LEDA | 2009 | 46 |
| K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25 | 2008 | 34 |
| K110375 | Blueshine's Gold Series | 2012 | 4 |
| K082445 | CURATIVE980 Diode Laser | 2008 | 0 |
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 12 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 7 of the 169 ancestors have a recall of any class.
- Of its descendants, K083613 (Quanta System Spa, 2008) has gone furthest, with 192 descendants of its own.
- 2 other devices also cite its predicate K042211.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
808 nm, 940 nm, 980 nm Wavelengths The Quanta System Diode Medical Lasers Family, (and the fiber delivery systems and accessories used to deliver laser energy), are 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)…
Read the full statement (1,198 words)
808 nm, 940 nm, 980 nm Wavelengths
The Quanta System Diode Medical Lasers Family, (and the fiber delivery systems and accessories used to deliver laser energy), are 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 Quanta System Diode Medical Lasers Family are 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 (Medical 30)
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 (Medical 30.6)
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 (Medical 30)
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 (Urology) (Medical 30)
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 (Medical 30)
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.
Gvnecology (GYN) (Medical 30)
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 acuminata, 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 (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions.
Ophthalmology (Medical 30)
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 (Medical 30
The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures, Applications include: Open: Dissect and coagulate.
Otolaryngology (ENT) (Medical 30)
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; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy; Head & Neck: tumor resection on oral, subfacial and neck tissues; parathyroidectomy; thyroidectomy.
In addition, at 808nm and 980nm wavelengths, the Quanta system Diode Medical Laser family is intended for the following use:
Urology (Medical 30):
Lesions of external genitalia; Circumcision; Condyloma; Bladder tumors; Bladder neck incisions; Vaporization of the prostate
Neurosurgery (Medical 30):
Percutaneous Disc Decompression; Discectomy; Hemostasis in conjunction with meningiomas
Arthroscopy (Medical 30):
Chondromalacia; Synovectomy; Menisectomy
Pulmonary Surgery (Medical 30):
Endoscopic pulmonary applications; Tracheal bronchial lesions; Benign and malignant pulmonary or stricture
Cardiac Surgery (Medical 30):
Coagulation and haemostasis of cardiac tissue
Dermatology/Aesthetics (Medical30):
Photocoagulation of vascular & dermatological lesions of the face and extremities; Photocoagulation of telangiectasia, veinulectasias of the legs and face; Treatment of reticular veins and branch varicosities; Pyogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas; Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Chery angioma, Hemangioma, Port wine stains, angiokeratoma, and benign ipidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.; Dermatology surgery: Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcomn. Warty leucoplasy and ulcers debridmnent; Seborrheic keratosis; Mixoid cyst; Papillary varix; Acne treatment; Hair removal of unwanted hair from skin type IV;
Plastic Surgery (Medical 30):
Cut, coagulation & vaporization; Blepharoplasy
Vascular Surgery (Medical 30):
Endoluminal or endovenus laser surgery for saphenous incompetent veins.
Dental applications (Medical 30. 6. 4):
Frenectomy; Frenotomy; Biopsy; Pulpotorny as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening
808 rnm Wavelength
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Quanta System Diode Medical Laser Family are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
940nm Wavelength
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in endlovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
The Quanta System Diode Medical Laser Family (Medical 30), is intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85cc and for cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endloscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non contact open surgery (with or without a handpiece).
It (Medical 30) is also intended for use in the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.
It (Medical 30) is also indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology.
The Quanta System Diode Laser Family (Medical 30, 6. 4) is also indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications:Excisional and incisional biopsiesExposure of unerupted teeth; Fibroma removal; Frenectomy; Frenotomy; Gingival troughing for crown impressions; Gingivectomy; Gingivoplasty; Gingival incision and excision; Haemostasis and coagulation; Implant recovery; Incision and drainage of abscess; Leukoplakia; Operculectomy; Oral papillectomies; Pulpotomny; Pulpotomy as an adjunct to root canal therapy; Reduction of gingival hypertrophy; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; Vestibuloplasty
The Quanta System Diode Laser Family (Medical 30. 6, 4) _is also indicated for Laser Periodontal procedures, including: Laser soft tissue curettage; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
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/K072034 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072034: Diode Medical Laser Family, Models 4, 6, 30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072034
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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