510(k) · Cleared
ClearedDermatological Carbon Dioxide Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhuolu Jontelaser Manufacturing Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Nov 25, 2020 as substantially equivalent to K192528 (Shangdong Huamei Technology Co., Ltd., 2019) after a 107-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Nov 25, 2020
- Review
- 107 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). No later device cites it as a predicate yet.
- 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 deviceK202250 Dermatological Carbon Dioxide Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd. · 2020
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) | K202250 | Dermatological Carbon Dioxide Laser Systems | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. | 2020 | — |
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 |
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 5…Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery; 6. Identification of Primary Predicate 510(k) Number: K192528 Product Name: CO2 Laser Therapy Machine Manufacturer: Shangdong Huamei Technology Co., Ltd. 7. Device Description… | 2019 |
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 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.
- 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 Dermatological Carbon Dioxide Laser 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/K202250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202250: Dermatological Carbon Dioxide Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202250
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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