510(k) · Cleared
ClearedDiode Laser Hair Removal Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Chuang Zao Mei Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jun 29, 2022 as substantially equivalent to K210663 (Beijing HuaCheng Taike Technology Co., Ltd., 2021) after a 55-day review. Its family tree reaches back 16 generations to 1992. 4 later devices descend from it.
- Decided
- Jun 29, 2022
- Review
- 55 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K910422 (1992). 64 ancestors in all, the oldest K871179 (1987). 4 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 12 generations between
- 3 generations backK162659 Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 2017
- 2 generations backK180353 Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd. · 2018
- 1 generation backK210663 Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd. · 2021
- This deviceK221312 Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK250431 Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK252048 808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243465 Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser…Guangzhou Chuang Zao Mei Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK241498 Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd · 2024
Show all 16 generations
- Root · 16 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 15 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 14 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 13 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 12 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 11 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 10 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 9 generations backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- 8 generations backK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- 7 generations backK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
- 6 generations backK112031 Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for…Alma Lasers, Inc. · 2011
- 5 generations backK123483 Diode LaserBeijing Syntech Laser CO., LTD. · 2013
- 4 generations backK141973 Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd. · 2014
- 3 generations backK162659 Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 2017
- 2 generations backK180353 Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd. · 2018
- 1 generation backK210663 Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd. · 2021
- This deviceK221312 Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd. · 2025 · cites it directly1descendant
- K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd. · 2025 · cites it directly0descendants
- K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −15 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −14 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −13 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −12 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −11 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −10 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −9 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| −8 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| −7 | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms | Alma Lasers, Inc. | 2010 | — |
| −6 | K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with… | Alma Lasers, Inc. | 2011 | — |
| −5 | K123483 | Diode Laser | Beijing Syntech Laser CO., LTD. | 2013 | — |
| −4 | K141973 | Diode Laser Hair Removal System | Beijing Anchorfree Technology Co., Ltd. | 2014 | — |
| −3 | K162659 | Diode Laser Hair Removal System | Shandong Huamei Technology Co., Ltd. | 2017 | — |
| −2 | K180353 | Diode laser hair removal device | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2018 | — |
| −1 | K210663 | Dermatological Diode Laser Systems | Beijing HuaCheng Taike Technology Co., Ltd. | 2021 | — |
| 0 (this device) | K221312 | Diode Laser Hair Removal Device | Guangzhou Chuang Zao Mei Technology Co., Ltd. | 2022 | — |
| +1 | K250431 | Medical Diode Laser Hair Removal System (MNLT-D1) | Shandong Moonlight Electronics Tech Co., Ltd. | 2025 | — |
| +2 | K252048 | 808nm semiconductor laser hair removal machine | Xi'An Taibo Electronic Technology Co., Ltd. | 2026 | — |
| +1 | K243465 | Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal… | Guangzhou Chuang Zao Mei Technology Co., Ltd. | 2025 | — |
| +1 | K241498 | Diode laser Treatment System (K18) | Hebei Keylaser Sci-Tech Co.,Ltd | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K210663 | Dermatological Diode Laser SystemsSummary page 5…: II Product Code: GEX Review Panel: General & Plastic Surgery IV. PREDICATE DEVICE 510(k) Number: K210663 Device Name: Dermatological Diode Laser Systems Manufacturer: Beijing HuaCheng Taike Technol… | 2021 |
What descends from it? (4)
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 30 years and passes through 14 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 64 ancestors have a recall of any class.
- Of its descendants, K250431 (Shandong Moonlight Electronics Tech Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K210663.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL) 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 as stated in the FDA summary.
https://510kreport.com/device/K221312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221312: Diode Laser Hair Removal Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221312
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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