510(k) · Cleared
Recalled · Class II · 2019Auriga XL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starmedtec GmbH · GEX Powered Laser Surgical Instrument
Cleared on Sep 28, 2011 as substantially equivalent to K033437 (Allmed Systems, Inc., 2004) after a 124-day review. Its family tree reaches back 1 generation to 2004. 5 later devices descend from it. It has been recalled 14 times.
- Decided
- Sep 28, 2011
- Review
- 124 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 14
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033437 (2004). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK033437 Sphinx Laser SystemsAllmed Systems, Inc. · 2004
- This deviceK111475 Auriga XLStarmedtec GmbH · 2011
- Descendant · cites it directly · 2 of its ownK131987 Multipulse HoplusAsclepion Laser Technologies GmbH · 2014
- Descendant · 2 generations on · 1 of its ownK161257 MultiPulse HoPLUSAsclepion Laser Technologies GmbH · 2017
- Descendant · cites it directly · 1 of its ownK121570 Auriga QIStarmedtec GmbH · 2013
- Descendant · 3 generations on · 0 of its ownK253633 Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK140964 Calculase IIKARL STORZ Endoscopy-America, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K131987Multipulse HoplusAsclepion Laser Technologies GmbH · 2014 · cites it directly2descendants
- K161257MultiPulse HoPLUSAsclepion Laser Technologies GmbH · 2017 · 2 generations on1descendant
- K121570Auriga QIStarmedtec GmbH · 2013 · cites it directly1descendant
- K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2026 · 3 generations on0descendants
- K140964Calculase IIKARL STORZ Endoscopy-America, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033437 | Sphinx Laser Systems | Allmed Systems, Inc. | 2004 | — |
| 0 (this device) | K111475 | Auriga XL | Starmedtec GmbH | 2011 | — |
| +1 | K131987 | Multipulse Hoplus | Asclepion Laser Technologies GmbH | 2014 | — |
| +2 | K161257 | MultiPulse HoPLUS | Asclepion Laser Technologies GmbH | 2017 | — |
| +1 | K121570 | Auriga QI | Starmedtec GmbH | 2013 | — |
| +3 | K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026 | — |
| +2 | K140964 | Calculase II | KARL STORZ Endoscopy-America, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 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 |
|---|---|---|---|
| * | K033437 | Sphinx Laser SystemsSummary page 1…Laser instrument, surgical, powered d. Product code: GEX 3. Predicate Device: Lisa Laser Products - Sphinx (510(k) Number: K033437) 4. Product Description: The Auriga XL is a holmium laser system, which emits laser radiation with a wavelength… | 2004 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2019 | Class II | Z-1396-2019 | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop… |
| Apr 8, 2019 | Class II | Z-1395-2019 | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop… |
| Apr 8, 2019 | Class II | Z-1393-2019 | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop… |
| Apr 8, 2019 | Class II | Z-1397-2019 | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop… |
| Apr 8, 2019 | Class II | Z-1392-2019 | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop… |
| Apr 8, 2019 | Class II | Z-1391-2019 | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop… |
| Apr 8, 2019 | Class II | Z-1394-2019 | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop… |
| Apr 8, 2019 | Class II | Z-1399-2019 | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop… |
| Apr 8, 2019 | Class II | Z-1398-2019 | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop… |
| Sep 22, 2017 | Class II | Z-0897-2018 | Process design | Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console. |
| Sep 22, 2017 | Class II | Z-0898-2018 | Process design | Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console. |
| Sep 30, 2014 | Class II | Z-0049-2015 | No Marketing Application | Product is not cleared for use with lasers other than the Auriga XL system |
| Sep 30, 2014 | Class II | Z-0050-2015 | No Marketing Application | Product is not cleared for use with lasers other than the Auriga XL system |
| Sep 30, 2014 | Class II | Z-0051-2015 | No Marketing Application | Product is not cleared for use with lasers other than the Auriga XL system |
The 5 latest of 14 recalls; the web page lists all.
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. 2011, 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 Auriga XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery Urology…
Read the full statement (567 words)
The Auriga XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialities including:
Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Strictures of urethra and ureter
- Bladder Neck Incisions (BNJ)
- Ablation and resecetion of Bladder Tumors, Uretheral Tumors and Ureteral Tumors
- Ablation of Benign Prostatic Hyperplasia (BPH)
- Transurethral incision of prostate (TUIP)
- Holmium Laser Resection of the prostate (HoLRP)
- Holmiumn Laser Enucleation of the prostate (HoLEP)
- Holmium Laser Ablation of the prostate (HoLap)
- Bladder/Renal calculi (Lithotripsy)
- Condylomas
- Lesions or external genitalia
- Lithotripsy
- Percutaneous Urinary Lithtripsy
- Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
- Endoscopic fragemnation of kidney calculi
- Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterolopy
Open and endoscopic gastroenterological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy
- Polyps
- Biopsy
- Gall Bladder Calculi (Lithotripsy)
- Biliary/Bile duct calculi (Lithotripsy)
- Ulcers
- Gastric ulcers
- Duodenal ulcers
- Non bleeding ulcers
- Pancreatitis
- Hemorrhoids
- Cholecystectomy
- Benign and malignant neoplasm
- Angiodysplasia
- Colorectal cancer
- Telangiectasias
- Telangiectasias of Osler-Weber-Renu disease
- Vascular malformation
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weiss tear
- Gastric Erosions
Arthroscopv
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilangenous tissue) in small and large joints of the body excluding the spine but including:
- Ligament and tendon Release
- Countouring and sculpting of articular surfaces
- Capsulectomnie in the knee
- Chondreoplasty in the knee
- Debridement of inflamed synovial tissue
- Chondromalacia ablation
- Chondtromalcia and tears
- Plica removal
- Meniscectomy
- Loose body debridement
- Lateral retineacular release
Ablation of soft, cartilanginous and bony tissue in minimal invasive spinal surgery including
- Percutaneous laser disc decompression/discectomy of the L4-5 and L5-S1 lumbar discs, including forminoplasty
- Percutaneous cervical disc decompression/discectomy
- Percutaneous thoracic disc decompression/discectomy
Thoracic and Pulmonary
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
Gynaecology
Open and endoscopic/laparoscopic gynaecoiogical surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis).
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue and cartilage) including:
- Endonasal / sinus surgery
- Partial turbinectomny
- Polypectomny
- Dacryocystorhinostomny
- Frontal sinustomny
- Ethmoidectomny
- Maxillary antrostomny
- Functional endoscopic sinus surgery
Dermatology and Plastic Surgery
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, muscosal tissue, fatty tissue and cartilaginous tissue in therapeutic plastic, dermatologid and aesthetic surgical procedures including:
- Basal Cell Carcinomas
- Lesion of skin and subcutaneous tissue
- Skin tags
- Plantar warts
- Lesions of skin and subcutaneous tissue
- Port wine stains
- Papillomas
General Surgery
Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy
- Biopsy
- Skin incision
- Excision of external tumours and lesions
- Complete or partial resection of internal organs, tumnours, lesions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111475 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111475: Auriga XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111475
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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