510(k) · Cleared
ClearedCO2 Laser Machine (Lume)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanjing Bestview Laser S&T Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jun 9, 2025 as substantially equivalent to K201109 (Shanghai Apolo Medical Technology Co., Ltd., 2020) and 1 other predicate after a 111-day review. Its family tree reaches back 21 generations to 1995.
- Decided
- Jun 9, 2025
- Review
- 111 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K943450 (1995). 358 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK133895 Deka Smartxide Laser SystemEl.En S.P.A. · 2014
- 2 generations backK162169 EdgeOne CO2 LaserJeisys Medical, Inc. · 2016
- 1 generation backK201109 CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
- This deviceK250465 CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd. · 2025
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 9 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 8 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 7 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 6 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 4 generations backK113504 Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa · 2013
- 3 generations backK133895 Deka Smartxide Laser SystemEl.En S.P.A. · 2014
- 2 generations backK162169 EdgeOne CO2 LaserJeisys Medical, Inc. · 2016
- 1 generation backK201109 CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
- This deviceK250465 CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −9 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −8 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −7 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −6 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −4 | K113504 | Deka Smartxide and Delivery Accessories | El.En Electronic Engineering Spa | 2013 | — |
| −3 | K133895 | Deka Smartxide Laser System | El.En S.P.A. | 2014 | — |
| −2 | K162169 | EdgeOne CO2 Laser | Jeisys Medical, Inc. | 2016 | — |
| −1 | K201109 | CO2 Laser Therapy System | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| 0 (this device) | K250465 | CO2 Laser Machine (Lume) | Nanjing Bestview Laser S&T Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 7 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 23 | 0 |
| 1995 | 20 | 0 |
| 1996 | 26 | 0 |
| 1997 | 27 | 0 |
| 1998 | 24 | 0 |
| 1999 | 18 | 0 |
| 2000 | 27 | 0 |
| 2001 | 29 | 0 |
| 2002 | 34 | 0 |
| 2003 | 29 | 0 |
| 2004 | 18 | 0 |
| 2005 | 11 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (2)
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 |
|---|---|---|---|
| * | K201109 | CO2 Laser Therapy SystemSummary page 6…System Model Lume HS-411 / / 510(k) Number K250465 K201109 K162169 / Product Code GEX GEX GEX… | 2020 |
| * | K162169 | EdgeOne CO2 LaserSummary page 6…Lume HS-411 / / 510(k) Number K250465 K201109 K162169 / Product Code GEX GEX GEX Same Regulat… | 2016 |
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 30 years and passes through 11 companies; a new generation was cleared every 11 months on median.
- 16 of the 358 ancestors have a recall of any class.
- 2 other devices also cite its predicate K201109.
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 CO2 Laser Machine (Lume) is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250465: CO2 Laser Machine (Lume).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250465
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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