510(k) · Cleared
ClearedDiode Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Huafei Tongda Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jul 16, 2018 as substantially equivalent to K162659 (Shandong Huamei Technology Co., Ltd., 2017) and 3 other predicates after a 90-day review. Its family tree reaches back 14 generations to 1992. 6 later devices descend from it.
- Decided
- Jul 16, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K910422 (1992). 84 ancestors in all, the oldest K871179 (1987). 6 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations between
- 3 generations backK123483 Diode LaserBeijing Syntech Laser CO., LTD. · 2013
- 2 generations backK141973 Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd. · 2014
- 1 generation backK162659 Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 2017
- This deviceK181019 Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK200525 Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK192569 Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK192516 Diode Laser 808nmBeijing Superlaser Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK241860 Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited · 2024
- Descendant · 2 generations on · 0 of its ownK202257 Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd. · 2021
Show all 14 generations
- Root · 14 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 13 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 12 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 11 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 10 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 9 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 8 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 7 generations backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- 6 generations backK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- 5 generations backK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
- 4 generations backK112031 Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for…Alma Lasers, Inc. · 2011
- 3 generations backK123483 Diode LaserBeijing Syntech Laser CO., LTD. · 2013
- 2 generations backK141973 Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd. · 2014
- 1 generation backK162659 Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 2017
- This deviceK181019 Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd. · 2020 · cites it directly1descendant
- K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd. · 2019 · cites it directly1descendant
- K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd. · 2019 · cites it directly1descendant
- K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited · 2024 · 2 generations on0descendants
- K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −13 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −12 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −11 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −10 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −9 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −8 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −7 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| −6 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| −5 | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms | Alma Lasers, Inc. | 2010 | — |
| −4 | K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with… | Alma Lasers, Inc. | 2011 | — |
| −3 | K123483 | Diode Laser | Beijing Syntech Laser CO., LTD. | 2013 | — |
| −2 | K141973 | Diode Laser Hair Removal System | Beijing Anchorfree Technology Co., Ltd. | 2014 | — |
| −1 | K162659 | Diode Laser Hair Removal System | Shandong Huamei Technology Co., Ltd. | 2017 | — |
| 0 (this device) | K181019 | Diode Laser System | Guangzhou Huafei Tongda Technology Co., Ltd. | 2018 | — |
| +1 | K200525 | Medical Diode Laser Hair Removal System | Weifang Mingliang Electronics Co., Ltd. | 2020 | — |
| +1 | K192569 | Diode Laser Therapy System | San HE Lefis Electronics Co., Ltd. | 2019 | — |
| +1 | K192516 | Diode Laser 808nm | Beijing Superlaser Technology Co., Ltd. | 2019 | — |
| +2 | K241860 | Diode Laser Hair Removal System | Beijing Winkonlaser Technology Limited | 2024 | — |
| +2 | K202257 | Dermatological Diode Laser Systems | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. | 2021 | — |
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 | 6 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (4)
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 |
|---|---|---|---|
| * | K162659 | Diode Laser Hair Removal SystemSummary page 7…7-3 510(k) Summary 6. Identification of Predicate Device 510(k) Number: K162659 Product Name: Diode Laser Hair Removal System Manufacturer: Shandong Huamei Technology Co.,ltd. 510(k) Number: K… | 2017 |
| * | K142845 | SILKPRO laser hair removal systemSummary page 7…cate Device 510(k) Number: K162659 Product Name: Diode Laser Hair Removal System Manufacturer: Shandong Huamei Technology Co.,ltd. 510(k) Number: K142845 Product Name: SILKPRO Laser Hair Removal System Manufacturer: Wuhan Lotuxs Technology Co., Ltd. 510(k) Number: K… | 2015 |
| * | K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Summary page 7…gy Co.,ltd. 510(k) Number: K142845 Product Name: SILKPRO Laser Hair Removal System Manufacturer: Wuhan Lotuxs Technology Co., Ltd. 510(k) Number: K112031 Product Name: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with Family of Soprano XL Multi-A… | 2011 |
| * | K153718 | Spirit Hair Removal laser FamilySummary page 7…Diode Laser Module with SHR Treatment Mode for use with Family of Soprano XL Multi-Application Platforms Manufacturer: Alma Lasers, Inc. 510(k) Number: K153718 Product Name: Spirit Hair Removal Laser Family. Spirit-918/cFactor -918/mFactor-918 Manufacturer: Active Optical System… | 2016 |
What descends from it? (6)
3 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 26 years and passes through 12 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 84 ancestors have a recall of any class.
- Of its descendants, K200525 (Weifang Mingliang Electronics Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K162659.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 System 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/K181019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181019: Diode 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/K181019
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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