510(k) · Cleared
ClearedNd: YAG Laser Therapy Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanhe Meditech Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Mar 31, 2026 as substantially equivalent to K202758 (Shangdong Huamei Technology Co., Ltd., 2020) after a 54-day review. Its family tree reaches back 15 generations to 1992.
- Decided
- Mar 31, 2026
- Review
- 54 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K910422 (1992). 131 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 backK190936 Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd. · 2019
- 1 generation backK202758 Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd. · 2020
- This deviceK260375 Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd. · 2026
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 backK190936 Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd. · 2019
- 1 generation backK202758 Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd. · 2020
- This deviceK260375 Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd. · 2026
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 | K190936 | Q-Switched Nd: YAG Laser System | Shanghai Apolo Medical Technology Co., Ltd. | 2019 | — |
| −1 | K202758 | Nd: YAG Laser Therapy Systems HM-YL900 | Shangdong Huamei Technology Co., Ltd. | 2020 | — |
| 0 (this device) | K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | 2026 | — |
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 | 11 | 0 |
| 2002 | 16 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K202758 | Nd: YAG Laser Therapy Systems HM-YL900Summary page 6…uct Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery; 5. Identification of Predicate Device(s) Predicate Device 510(k) Number: K202758 Product Name: Nd: YAG Laser Therapy Systems HM-YL900 Manufacturer: Shangdong Huamei Technology Co., Ltd. Reference Device 510(… | 2020 |
| † | K200525 | Medical Diode Laser Hair Removal System | 2020 |
| † | K193477 | Nd: YAG Laser Therapy Systems | 2020 |
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 34 years and passes through 10 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 131 ancestors have a recall of any class.
- 1 other device also cites its predicate K202758.
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 Nd: YAG Laser Therapy Systems is intended 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: 532nm wavelength: ● Removal of light ink (red, sky blue, green, purple, and orange) tattoo. ● Treatment of benign vascular lesions including, but not limited to: telangiectasias. ● Treatment of benign epidermal…
Read the full statement (146 words)
The Nd: YAG Laser Therapy Systems is intended 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:
532nm wavelength:
● Removal of light ink (red, sky blue, green, purple, and orange) tattoo.
● Treatment of benign vascular lesions including, but not limited to: telangiectasias.
● Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi, freckles, Nevus spilus, Seborrheic Keratoses.
● Treatment of Post Inflammatory Hyper-Pigmentation.
1064nm wavelength:
● Removal dark ink (black, blue and brown) tattoo.
● Removal of benign dermal pigmented lesions including, but not limited to: Nevus of Ota, Common Nevi, and Melasma.
● Removal or lightening of unwanted hair with or without adjuvant preparation.
● Skin resurfacing procedures for the treatment of acne scars and wrinkles.
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/K260375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260375: 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/K260375
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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