510(k) · Cleared
ClearedCO2 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Superlaser Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jun 9, 2020 as substantially equivalent to K192528 (Shangdong Huamei Technology Co., Ltd., 2019) after a 153-day review. Its family tree reaches back 8 generations to 1994. 5 later devices descend from it.
- Decided
- Jun 9, 2020
- Review
- 153 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K936109 (1994). 20 ancestors in all, the oldest K853620 (1986). 5 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 6 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 5 generations backK063001 Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007
- 4 generations backK101555 CO2 Laser SystemAdvanced Technology Laser Co., Ltd. · 2010
- 3 generations backK110434 Trixel CO2 LaserBeijing Syntech Laser CO., LTD. · 2011
- 2 generations backK161925 CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd. · 2016
- 1 generation backK192528 CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd. · 2019
- This deviceK200042 CO2 Laser SystemBeijing Superlaser Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK262269 CO2 Laser System (MBT- CO2 Laser)Beijing Mega Beauty Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK260257 CO2 Laser SystemSanhe Meditech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK253920 CO2 Laser Treatment Machine (CFR3M1)Haidari Beauty Technology (Beijing) Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK250183 CO2 Laser System (CO2 Laser SST-L23)Zhuozhou Summer Star Technologies Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK211735 CO2 Laser Machine, Model: BW-203BZhengzhou Bestview ST Co., Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K262269CO2 Laser System (MBT- CO2 Laser)Beijing Mega Beauty Technology Co., Ltd. · 2026 · cites it directly0descendants
- K260257CO2 Laser SystemSanhe Meditech Co., Ltd. · 2026 · cites it directly0descendants
- K253920CO2 Laser Treatment Machine (CFR3M1)Haidari Beauty Technology (Beijing) Co., Ltd. · 2026 · cites it directly0descendants
- K250183CO2 Laser System (CO2 Laser SST-L23)Zhuozhou Summer Star Technologies Co., Ltd. · 2025 · cites it directly0descendants
- K211735CO2 Laser Machine, Model: BW-203BZhengzhou Bestview ST Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −7 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −5 | K063001 | Slim Evolution Family of CO2 Lasers and Delivery Device Accessories | Lasering S.R.L. | 2007 | — |
| −4 | K101555 | CO2 Laser System | Advanced Technology Laser Co., Ltd. | 2010 | — |
| −3 | K110434 | Trixel CO2 Laser | Beijing Syntech Laser CO., LTD. | 2011 | — |
| −2 | K161925 | CO2 Laser Therapy Machine | Beijing Adss Development Co., Ltd. | 2016 | — |
| −1 | K192528 | CO2 Laser Therapy System | Shangdong Huamei Technology Co., Ltd. | 2019 | — |
| 0 (this device) | K200042 | CO2 Laser System | Beijing Superlaser Technology Co., Ltd. | 2020 | — |
| +1 | K262269 | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | 2026 | — |
| +1 | K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | 2026 | — |
| +1 | K253920 | CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., Ltd. | 2026 | — |
| +1 | K250183 | CO2 Laser System (CO2 Laser SST-L23) | Zhuozhou Summer Star Technologies Co., Ltd. | 2025 | — |
| +1 | K211735 | CO2 Laser Machine, Model: BW-203B | Zhengzhou Bestview ST Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K192528 | CO2 Laser Therapy SystemSummary page 4…surgery and in dermatology Review Panel: General & Plastic Surgery 6. Identification of the Primary Predicate 510(k) Number: K192528 Device Name: CO2 Laser Therapy System Manufacturer: Shangdong Huamei Technology Co., Ltd. 7. Device… | 2019 |
| † | K161925 | CO2 Laser Therapy Machine | 2016 |
What descends from it? (5)
5 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 26 years and passes through 8 companies; a new generation was cleared every 3.2 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K262269 (Beijing Mega Beauty Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K192528.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200042 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200042: CO2 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200042
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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