510(k) · Cleared
ClearedAuriga QI
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 Jan 16, 2013 as substantially equivalent to K111475 (Starmedtec GmbH, 2011) after a 232-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Jan 16, 2013
- Review
- 232 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033437 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK033437 Sphinx Laser SystemsAllmed Systems, Inc. · 2004
- 1 generation backK111475 Auriga XLStarmedtec GmbH · 2011 · Recalled
- This deviceK121570 Auriga QIStarmedtec GmbH · 2013
- Descendant · cites it directly · 0 of its ownK140964 Calculase IIKARL STORZ Endoscopy-America, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140964Calculase IIKARL STORZ Endoscopy-America, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033437 | Sphinx Laser Systems | Allmed Systems, Inc. | 2004 | — |
| −1 | K111475 | Auriga XL | Starmedtec GmbH | 2011 | 14 |
| 0 (this device) | K121570 | Auriga QI | Starmedtec GmbH | 2013 | — |
| +1 | K140964 | Calculase II | KARL STORZ Endoscopy-America, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K111475 | Auriga XLSummary page 1…Laser instrument, surgical, powered d. Product code: GEX 3. Predicate Device: StarMed1Tec GmbH - Auriga XL (51 0(k) Number: 1111475) 4. Product Description: The Auriga 01 is a holmium laser system, which emits laser radiation with a wavelength… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140964 | Calculase II | 2014 | 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 9 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K140964 (KARL STORZ Endoscopy-America, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K111475.
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 Auriga QI 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…
Read the full statement (246 words)
The Auriga QI 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
Dermiatology and Plastic Surgery
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, mucosal tissue, fatty tissue and cartilaginous tissue in therapeutic plastic, dermatologic 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 hernostasis) including:
- Appendectomy
- Biopsy
- Skin incision
- Excision of external tumnours; and lesions
- Complete or partial resection of internal organs, tumnours, lesions
Gastroenterology
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121570: Auriga QI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121570
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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