510(k) · Cleared
ClearedQ-Switched Nd: YAG Laser machine (LFS-C13U)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanhe Lefis Electronics Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Oct 20, 2025 as substantially equivalent to K193609 (Beijing Lead Beauty S & T Co., Ltd., 2020) and 1 other predicate after an 87-day review. Its family tree reaches back 15 generations to 1992.
- Decided
- Oct 20, 2025
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K910422 (1992). 135 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.
- Root · 15 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations between
- 3 generations backK113588 Spectra Laser SystemLutronic Corporation · 2012
- 2 generations backK122922 E-Beam ND: Yag LaserEclipse Aesthetics, LLC · 2013
- 1 generation backK173038 CuRAS Nd:YAG LaserIlooda Co,., Ltd. · 2017
- This deviceK252319 Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd. · 2025
Show all 15 generations
- Root · 15 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 14 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 13 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 12 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 11 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 10 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 9 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 8 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 7 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 6 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 5 generations backK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
- 4 generations backK103455 Spectra Laser SystemLutronic Corporation · 2011
- 3 generations backK113588 Spectra Laser SystemLutronic Corporation · 2012
- 2 generations backK122922 E-Beam ND: Yag LaserEclipse Aesthetics, LLC · 2013
- 1 generation backK173038 CuRAS Nd:YAG LaserIlooda Co,., Ltd. · 2017
- This deviceK252319 Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −14 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −13 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −12 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −11 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −10 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −9 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −8 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −7 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| −6 | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| −5 | K083889 | Fotona QX ND:Yag/KTP Laser System Family | Fotona D.D. | 2009 | — |
| −4 | K103455 | Spectra Laser System | Lutronic Corporation | 2011 | — |
| −3 | K113588 | Spectra Laser System | Lutronic Corporation | 2012 | — |
| −2 | K122922 | E-Beam ND: Yag Laser | Eclipse Aesthetics, LLC | 2013 | — |
| −1 | K173038 | CuRAS Nd:YAG Laser | Ilooda Co,., Ltd. | 2017 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 13 | 0 |
| 2001 | 12 | 0 |
| 2002 | 16 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K193609 | Q Switched Nd: YAG Laser machineSummary page 7…chine has passed the Biocompatibility test. For details, please refer to "Biocompatibility Discussion". 9. Identification of Predicate Device(s) 510(k) Number: K193609 Product Name: Q-Switched Nd: YAG Laser machine Manufacturer: Beijing Lead Beauty S&T Co., Ltd. 510(k) Number: K… | 2020 |
| * | K173038 | CuRAS Nd:YAG LaserSummary page 7…e Device(s) 510(k) Number: K193609 Product Name: Q-Switched Nd: YAG Laser machine Manufacturer: Beijing Lead Beauty S&T Co., Ltd. 510(k) Number: K173038 Product Name: CuRAS Nd:YAG Laser Manufacturer: Ilooda Co., Ltd 10. Non-Clinical Test Conclusion Non clinical… | 2017 |
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 33 years and passes through 10 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 135 ancestors have a recall of any class.
- 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. 2025, 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 as stated in the FDA summary.
https://510kreport.com/device/K252319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252319: Q-Switched Nd: YAG Laser machine (LFS-C13U).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252319
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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