510(k) · Cleared
ClearedHolmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Nov 24, 2025 as substantially equivalent to K201455 (Quanta System Spa, 2020) after an 83-day review. Its family tree reaches back 13 generations to 1994.
- Decided
- Nov 24, 2025
- Review
- 83 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K936109 (1994). 40 ancestors in all, the oldest K853620 (1986). No later device cites it as a predicate yet.
- Root · 13 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 9 generations between
- 3 generations backK180922 Empower H100, Cyber Ho 100, Litho 100Quanta System Spa · 2018
- 2 generations backK192600 Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa · 2020
- 1 generation backK201455 Litho 150, Cyber Ho 150Quanta System Spa · 2020
- This deviceK252771 Holmium Laser System (Potent HP90); Holmium Laser System (Potent…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025
Show all 13 generations
- Root · 13 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 12 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 11 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 10 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 9 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 8 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 7 generations backK140388 Lumenis Pulse 120HLumenis, Ltd. · 2014
- 6 generations backK163009 LithoQuanta System Spa · 2016
- 5 generations backK170331 Cyber HoQuanta System Spa · 2017
- 4 generations backK172025 Litho 60Quanta System Spa · 2017
- 3 generations backK180922 Empower H100, Cyber Ho 100, Litho 100Quanta System Spa · 2018
- 2 generations backK192600 Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa · 2020
- 1 generation backK201455 Litho 150, Cyber Ho 150Quanta System Spa · 2020
- This deviceK252771 Holmium Laser System (Potent HP90); Holmium Laser System (Potent…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −12 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −11 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −10 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −9 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −8 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −7 | K140388 | Lumenis Pulse 120H | Lumenis, Ltd. | 2014 | — |
| −6 | K163009 | Litho | Quanta System Spa | 2016 | — |
| −5 | K170331 | Cyber Ho | Quanta System Spa | 2017 | — |
| −4 | K172025 | Litho 60 | Quanta System Spa | 2017 | — |
| −3 | K180922 | Empower H100, Cyber Ho 100, Litho 100 | Quanta System Spa | 2018 | — |
| −2 | K192600 | Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 | Quanta System Spa | 2020 | — |
| −1 | K201455 | Litho 150, Cyber Ho 150 | Quanta System Spa | 2020 | — |
| 0 (this device) | K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100)… | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K201455 | Litho 150, Cyber Ho 150Summary page 6…e Device Manufacturer 510(k) Number Primary Litho 150 / Cyber Ho 150 Holmium Quanta System S.p.A. K201455 Predicate Laser System Reference MultiPulse HoPlus Holmium Laser Asclepion Laser Technologies K161257 Device Sy… | 2020 |
| † | K161257 | MultiPulse HoPLUS | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 40 ancestors has a recall of any class.
- 2 other devices also cite its predicate K201455.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Holmium laser system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynecology, ENT and General Surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252771 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252771: Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252771
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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