510(k) · Cleared
ClearedND: Yag Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Toplaser Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Feb 28, 2014 as substantially equivalent to K014234 (Continuum Electro-Optics, Inc., 2002) and 1 other predicate after a 134-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it.
- Decided
- Feb 28, 2014
- Review
- 134 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011677 (2001). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011677 Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3…Continuum Electro-Optics, Inc. · 2001
- This deviceK133158 ND: Yag Laser SystemBeijing Toplaser Technology Co., Ltd. · 2014
- Descendant · cites it directly · 4 of its ownK163123 Q-Switched Nd:YAG Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co. · 2017
- Descendant · 2 generations on · 2 of its ownK193609 Q Switched Nd: YAG Laser machineBeijing Lead Beauty S & T Co., Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK261841 Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK252319 Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK242943 Q Switched Nd:YAG Laser machine (QNHF-01)Beijing Nubway S&T Co., Ltd. · 2025
Most influential descendants
Showing 5 of 5 · See all- K163123Q-Switched Nd:YAG Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co. · 2017 · cites it directly4descendants
- K193609Q Switched Nd: YAG Laser machineBeijing Lead Beauty S & T Co., Ltd. · 2020 · 2 generations on2descendants
- K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd. · 2026 · 3 generations on0descendants
- K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd. · 2025 · 3 generations on0descendants
- K242943Q Switched Nd:YAG Laser machine (QNHF-01)Beijing Nubway S&T Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011677 | Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag… | Continuum Electro-Optics, Inc. | 2001 | — |
| 0 (this device) | 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 | — |
| +2 | K193609 | Q Switched Nd: YAG Laser machine | Beijing Lead Beauty S & T Co., Ltd. | 2020 | — |
| +3 | K261841 | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | 2026 | — |
| +3 | K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U) | Sanhe Lefis Electronics Co., Ltd. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K014234 | Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag LaserSummary page 1…Number: 21 CFR 878.481 0 Product Code: GEX Panel: General and Plastic Surgery Model: QMetrxl 000 (Victory-lI1) 4. Predicate Device Medlite C6 Q-Switched Nd: YAG Laser (K014234) Medlite TM C3 Q-Switched Nd: YAG Laser (K011677) Manufactured by Continuum Electro-Optics. Inc. 5. Device Description The Nd:… | 2002 |
| * | K011677 | Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag LaserSummary page 1…: General and Plastic Surgery Model: QMetrxl 000 (Victory-lI1) 4. Predicate Device Medlite C6 Q-Switched Nd: YAG Laser (K014234) Medlite TM C3 Q-Switched Nd: YAG Laser (K011677) Manufactured by Continuum Electro-Optics. Inc. 5. Device Description The Nd: YAG Laser System is based on the 0-Switched Nd:YA… | 2001 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163123 | Q-Switched Nd:YAG Laser Therapy Systems | 2017 | 4 |
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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
* Tattoo Removal * Treatment of Vascular Lesions * Treatment of Pigmented Lesions, * Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology 1064nm 532nm Tattoo Removal Tattoo Removal * Dark ink: blue and black 6 Light Ink: red * Light ink: sky blue and green Treatment of Pigmented Lesions Treatment of Vascular Lesions * Nevus of ota * Port wine birthmarks * Telangiectasias * Spider angioma * Cherry angioma * Spider nevi…
Read the full statement (95 words)
* Tattoo Removal
* Treatment of Vascular Lesions
* Treatment of Pigmented Lesions,
* Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
1064nm 532nm
Tattoo Removal Tattoo Removal
* Dark ink: blue and black 6 Light Ink: red
* Light ink: sky blue and green
Treatment of Pigmented Lesions Treatment of Vascular Lesions
* Nevus of ota * Port wine birthmarks
* Telangiectasias
* Spider angioma
* Cherry angioma
* Spider nevi
Treatment of Pigmented Lesions
* Caf&-au-Iait birthmarks
* Solar lentiginos
* Senile lentiginos
" Becker's nevi
* Freckles
* Nevus spilus
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133158: ND: Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133158
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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