510(k) · Cleared
ClearedQ-Switched Nd:YAG Laser Therapy Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Sincoheren Science and Technology Development Co. · GEX Powered Laser Surgical Instrument
Cleared on Feb 2, 2017 as substantially equivalent to K133158 (Beijing Toplaser Technology Co., Ltd., 2014) after an 86-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Feb 2, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011677 (2001). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011677 Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3…Continuum Electro-Optics, Inc. · 2001
- 1 generation backK133158 ND: Yag Laser SystemBeijing Toplaser Technology Co., Ltd. · 2014
- This deviceK163123 Q-Switched Nd:YAG Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co. · 2017
- Descendant · cites it directly · 2 of its ownK193609 Q Switched Nd: YAG Laser machineBeijing Lead Beauty S & T Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK261841 Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK252319 Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242943 Q Switched Nd:YAG Laser machine (QNHF-01)Beijing Nubway S&T Co., Ltd. · 2025
Most influential descendants
Showing 4 of 4 · See all- K193609Q Switched Nd: YAG Laser machineBeijing Lead Beauty S & T Co., Ltd. · 2020 · cites it directly2descendants
- K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd. · 2026 · 2 generations on0descendants
- K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd. · 2025 · 2 generations on0descendants
- K242943Q Switched Nd:YAG Laser machine (QNHF-01)Beijing Nubway S&T Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011677 | Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag… | Continuum Electro-Optics, Inc. | 2001 | — |
| −1 | K133158 | ND: Yag Laser System | Beijing Toplaser Technology Co., Ltd. | 2014 | — |
| 0 (this device) | 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 | — |
| +2 | K261841 | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | 2026 | — |
| +2 | K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U) | Sanhe Lefis Electronics Co., Ltd. | 2025 | — |
| +1 | K242943 | Q Switched Nd:YAG Laser machine (QNHF-01) | Beijing Nubway S&T 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K133158 | ND: Yag Laser SystemSummary page 5…1/5 510(k) Premarket Notification Submission III. PREDICATE DEVICE Nd: YAG Laser System, K133158 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEVICE… | 2014 |
What descends from it? (4)
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 16 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K193609 (Beijing Lead Beauty S & T Co., Ltd., 2020) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 (1064nm or 532nm) 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…
Read the full statement (99 words)
The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) 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/K163123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163123: Q-Switched Nd:YAG Laser Therapy Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163123
Report an extraction error
Are you the manufacturer?
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