510(k) · Cleared
ClearedQ Switched Nd: YAG Laser machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Lead Beauty S & T Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Mar 20, 2020 as substantially equivalent to K163123 (Beijing Sincoheren Science and Technology Development Co., 2017) after an 85-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Mar 20, 2020
- Review
- 85 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011677 (2001). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK011677 Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3…Continuum Electro-Optics, Inc. · 2001
- 2 generations backK133158 ND: Yag Laser SystemBeijing Toplaser Technology Co., Ltd. · 2014
- 1 generation backK163123 Q-Switched Nd:YAG Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co. · 2017
- This deviceK193609 Q Switched Nd: YAG Laser machineBeijing Lead Beauty S & T Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK261841 Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252319 Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011677 | Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag… | Continuum Electro-Optics, Inc. | 2001 | — |
| −2 | K133158 | ND: Yag Laser System | Beijing Toplaser Technology Co., Ltd. | 2014 | — |
| −1 | K163123 | Q-Switched Nd:YAG Laser Therapy Systems | Beijing Sincoheren Science and Technology Development Co. | 2017 | — |
| 0 (this device) | K193609 | Q Switched Nd: YAG Laser machine | Beijing Lead Beauty S & T Co., Ltd. | 2020 | — |
| +1 | K261841 | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | 2026 | — |
| +1 | K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U) | Sanhe Lefis Electronics Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K163123 | Q-Switched Nd:YAG Laser Therapy SystemsSummary page 6…K193609 Page 3 of 5 510(k) Summary 5. Identification of Predicate Device 510(k) Number: K163123 Product Name: Q-Switched Nd:YAG Laser Systems Manufacturer: Beijing Sincoheren Science and Technology Development C… | 2017 |
What descends from it? (2)
2 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 19 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K261841 (Beijing Nubway S&T Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K163123.
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 Q-Switched Nd: YAG Laser Therapy System 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 as stated in the FDA summary.
https://510kreport.com/device/K193609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193609: Q Switched Nd: YAG Laser machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193609
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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