510(k) · Cleared
ClearedQ Switched Nd:YAG Laser machine (QLQW-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Nubway S&T Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Aug 11, 2026 as substantially equivalent to K193609 (Beijing Lead Beauty S & T Co., Ltd., 2020) after a 69-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Aug 11, 2026
- Review
- 69 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011677 (2001). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK011677 Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3…Continuum Electro-Optics, Inc. · 2001
- 3 generations backK133158 ND: Yag Laser SystemBeijing Toplaser Technology Co., Ltd. · 2014
- 2 generations backK163123 Q-Switched Nd:YAG Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co. · 2017
- 1 generation backK193609 Q Switched Nd: YAG Laser machineBeijing Lead Beauty S & T Co., Ltd. · 2020
- This deviceK261841 Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011677 | Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag… | Continuum Electro-Optics, Inc. | 2001 | — |
| −3 | K133158 | ND: Yag Laser System | Beijing Toplaser Technology Co., Ltd. | 2014 | — |
| −2 | K163123 | Q-Switched Nd:YAG Laser Therapy Systems | Beijing Sincoheren Science and Technology Development Co. | 2017 | — |
| −1 | K193609 | Q Switched Nd: YAG Laser machine | Beijing Lead Beauty S & T Co., Ltd. | 2020 | — |
| 0 (this device) | K261841 | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K193609 | Q Switched Nd: YAG Laser machineSummary page 6…1/6 510(k) Summary 5. Identification of Predicate Device(s) Predicate device: 510(k) Number: K193609 Product Name: Q Switched Nd:YAG Laser machine Manufacturer: Beijing Lead Beauty S & T Co., Ltd Reference Device:… | 2020 |
| † | K152856 | Helios III | 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 25 years and passes through 5 companies; a new generation was cleared every 6.4 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K193609.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Q Switched Nd:YAG Laser machine is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows:
1064nm:
-Tattoo Removal
Dark ink: blue and black.
-Treatment of Benign Pigmented Lesions
Nevus of ota.
532nm:
-Tattoo Removal
Light ink: red, Light ink: sky blue and green.
-Treatment of Benign Vascular Lesions
Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi.
-Treatment of Benign Pigmented Lesions
Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261841 · printed Nov 5, 2026
Cite this page
510(k) Report. “K261841: Q Switched Nd:YAG Laser machine (QLQW-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K261841
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026