510(k) · Cleared
ClearedLITHO
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 Aug 8, 2014 as substantially equivalent to K091909 (Quanta System Spa, 2009) after a 101-day review. Its family tree reaches back 2 generations to 2004. 14 later devices descend from it.
- Decided
- Aug 8, 2014
- Review
- 101 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033437 (2004). 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK033437 Sphinx Laser SystemsAllmed Systems, Inc. · 2004
- 1 generation backK091909 Litho Laser SystemQuanta System Spa · 2009
- This deviceK141101 LITHOQuanta System Spa · 2014
- Descendant · cites it directly · 12 of its ownK163009 LithoQuanta System Spa · 2016
- Descendant · 2 generations on · 9 of its ownK170331 Cyber HoQuanta System Spa · 2017
- Descendant · 3 generations on · 8 of its ownK172025 Litho 60Quanta System Spa · 2017
- Descendant · 4 generations on · 6 of its ownK180922 Empower H100, Cyber Ho 100, Litho 100Quanta System Spa · 2018
- Descendant · 4 generations on · 5 of its ownK192600 Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K163009LithoQuanta System Spa · 2016 · cites it directly12descendants
- K170331Cyber HoQuanta System Spa · 2017 · 2 generations on9descendants
- K172025Litho 60Quanta System Spa · 2017 · 3 generations on8descendants
- K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa · 2018 · 4 generations on6descendants
- K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa · 2020 · 4 generations on5descendants
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 | K091909 | Litho Laser System | Quanta System Spa | 2009 | — |
| 0 (this device) | K141101 | LITHO | Quanta System Spa | 2014 | — |
| +1 | K163009 | Litho | Quanta System Spa | 2016 | — |
| +2 | K170331 | Cyber Ho | Quanta System Spa | 2017 | — |
| +3 | K172025 | Litho 60 | Quanta System Spa | 2017 | — |
| +4 | K180922 | Empower H100, Cyber Ho 100, Litho 100 | Quanta System Spa | 2018 | — |
| +4 | K192600 | Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 | Quanta System Spa | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K091909 | Litho Laser SystemSummary page 1…and plastic surgery and in dermatology. Regulation Number: 21 CFR 878.4810 Product Code: GEX Basis for Submission: Device modifications Legally Marketed Device Litho (K091909) The modified device Litho is claimed to be derived from the legally marketed (unmodified) device Litho (K091909) because of Dev… | 2009 |
What descends from it? (14)
See all 142 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 10 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K163009 (Quanta System Spa, 2016) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K091909.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
INTENDED USE The device Litho 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 and in Lithotripsy of stones. INDICATIONS FOR USE The device Litho including a fiber optic delivery system is indicated for use in surgical procedures such as open, laparoscopic and…
Read the full statement (116 words)
INTENDED USE
The device Litho 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 and in Lithotripsy of stones.
INDICATIONS FOR USE
The device Litho including a fiber optic delivery system is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones in medical specialties including, but not limited to:
- Urology
- Gastroenterology
- Arthroscopy
- Neurosurgery
- Pulmonary
- Gynecology
- ENT
- Dermatology
- Plastic Surgery
- General 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/K141101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141101: LITHO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141101
Report an extraction error
Are you the manufacturer?
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