510(k) · Cleared
ClearedDiode laser device (BM091)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hebei Newangie Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Aug 8, 2025 as substantially equivalent to K232709 (Hebei Zhemai Technology Co., Ltd., 2023) after a 57-day review. Its family tree reaches back 17 generations to 1992.
- Decided
- Aug 8, 2025
- Review
- 57 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K910422 (1992). 65 ancestors in all, the oldest K871179 (1987). No later device cites it as a predicate yet.
- Root · 17 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 13 generations between
- 3 generations backK180353 Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd. · 2018
- 2 generations backK210663 Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd. · 2021
- 1 generation backK232709 Diode laser therapy deviceHebei Zhemai Technology Co., Ltd. · 2023
- This deviceK251801 Diode laser device (BM091)Hebei Newangie Technology Co., Ltd. · 2025
Show all 17 generations
- Root · 17 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 16 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 15 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 14 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 13 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 12 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 11 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 10 generations backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- 9 generations backK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- 8 generations backK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
- 7 generations backK112031 Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for…Alma Lasers, Inc. · 2011
- 6 generations backK123483 Diode LaserBeijing Syntech Laser CO., LTD. · 2013
- 5 generations backK141973 Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd. · 2014
- 4 generations backK162659 Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 2017
- 3 generations backK180353 Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd. · 2018
- 2 generations backK210663 Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd. · 2021
- 1 generation backK232709 Diode laser therapy deviceHebei Zhemai Technology Co., Ltd. · 2023
- This deviceK251801 Diode laser device (BM091)Hebei Newangie Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −16 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −15 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −14 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −13 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −12 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −11 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −10 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| −9 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| −8 | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms | Alma Lasers, Inc. | 2010 | — |
| −7 | K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with… | Alma Lasers, Inc. | 2011 | — |
| −6 | K123483 | Diode Laser | Beijing Syntech Laser CO., LTD. | 2013 | — |
| −5 | K141973 | Diode Laser Hair Removal System | Beijing Anchorfree Technology Co., Ltd. | 2014 | — |
| −4 | K162659 | Diode Laser Hair Removal System | Shandong Huamei Technology Co., Ltd. | 2017 | — |
| −3 | K180353 | Diode laser hair removal device | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2018 | — |
| −2 | K210663 | Dermatological Diode Laser Systems | Beijing HuaCheng Taike Technology Co., Ltd. | 2021 | — |
| −1 | K232709 | Diode laser therapy device | Hebei Zhemai Technology Co., Ltd. | 2023 | — |
| 0 (this device) | K251801 | Diode laser device (BM091) | Hebei Newangie Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K232709 | Diode laser therapy deviceSummary page 6…I Product Code: GEX Regulation Number: 878.4810 Review Panel: General & Plastic Surgery 5. Identification of Predicate Device(s) 510(k) Number: K232709 Product Name: Diode laser therapy device Manufacturer: Hebei Zhemai Technology Co., Ltd Reference Device: 5… | 2023 |
| † | K241642 | Diode Laser Hair Removal System (MBT-Diode Laser) | 2024 |
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 15 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 65 ancestors have a recall of any class.
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 Diode laser device is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI),including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
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/K251801 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251801: Diode laser device (BM091).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251801
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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