510(k) · Cleared
ClearedCO2 Laser Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shangdong Huamei Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Dec 3, 2019 as substantially equivalent to K161925 (Beijing Adss Development Co., Ltd., 2016) after an 81-day review. Its family tree reaches back 7 generations to 1994. 8 later devices descend from it.
- Decided
- Dec 3, 2019
- Review
- 81 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K936109 (1994). 19 ancestors in all, the oldest K853620 (1986). 8 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 6 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 5 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 4 generations backK063001 Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007
- 3 generations backK101555 CO2 Laser SystemAdvanced Technology Laser Co., Ltd. · 2010
- 2 generations backK110434 Trixel CO2 LaserBeijing Syntech Laser CO., LTD. · 2011
- 1 generation backK161925 CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd. · 2016
- This deviceK192528 CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd. · 2019
- Descendant · cites it directly · 5 of its ownK200042 CO2 Laser SystemBeijing Superlaser Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK262269 CO2 Laser System (MBT- CO2 Laser)Beijing Mega Beauty Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK260257 CO2 Laser SystemSanhe Meditech Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK253920 CO2 Laser Treatment Machine (CFR3M1)Haidari Beauty Technology (Beijing) Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK250183 CO2 Laser System (CO2 Laser SST-L23)Zhuozhou Summer Star Technologies Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K200042CO2 Laser SystemBeijing Superlaser Technology Co., Ltd. · 2020 · cites it directly5descendants
- K262269CO2 Laser System (MBT- CO2 Laser)Beijing Mega Beauty Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K260257CO2 Laser SystemSanhe Meditech Co., Ltd. · 2026 · 2 generations on0descendants
- K253920CO2 Laser Treatment Machine (CFR3M1)Haidari Beauty Technology (Beijing) Co., Ltd. · 2026 · 2 generations on0descendants
- K250183CO2 Laser System (CO2 Laser SST-L23)Zhuozhou Summer Star Technologies Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −6 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −4 | K063001 | Slim Evolution Family of CO2 Lasers and Delivery Device Accessories | Lasering S.R.L. | 2007 | — |
| −3 | K101555 | CO2 Laser System | Advanced Technology Laser Co., Ltd. | 2010 | — |
| −2 | K110434 | Trixel CO2 Laser | Beijing Syntech Laser CO., LTD. | 2011 | — |
| −1 | K161925 | CO2 Laser Therapy Machine | Beijing Adss Development Co., Ltd. | 2016 | — |
| 0 (this device) | K192528 | CO2 Laser Therapy System | Shangdong Huamei Technology Co., Ltd. | 2019 | — |
| +1 | K200042 | CO2 Laser System | Beijing Superlaser Technology Co., Ltd. | 2020 | — |
| +2 | K262269 | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | 2026 | — |
| +2 | K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | 2026 | — |
| +2 | K253920 | CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., Ltd. | 2026 | — |
| +2 | K250183 | CO2 Laser System (CO2 Laser SST-L23) | Zhuozhou Summer Star Technologies Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K161925 | CO2 Laser Therapy MachineSummary page 5…1 510(k) Summary Review Panel: General& Plastic Surgery; 4. Identification of Predicate Device 510(k) Number: K161925 Product Name: CO2 Laser Therapy Machine Manufacturer: Beijing ADSS Development Co., Ltd 5. Device Description… | 2016 |
What descends from it? (8)
3 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 25 years and passes through 7 companies; a new generation was cleared every 3.2 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K200042 (Beijing Superlaser Technology Co., Ltd., 2020) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K161925.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Therapy System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192528 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192528: CO2 Laser Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192528
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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