510(k) · Cleared
ClearedDermatological Diode Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing HuaCheng Taike Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Apr 26, 2021 as substantially equivalent to K180353 (Zhengzhou PZ Laser Slim Technology Co., Ltd., 2018) after a 52-day review. Its family tree reaches back 15 generations to 1992. 8 later devices descend from it.
- Decided
- Apr 26, 2021
- Review
- 52 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K910422 (1992). 63 ancestors in all, the oldest K871179 (1987). 8 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations between
- 3 generations backK141973 Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd. · 2014
- 2 generations backK162659 Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 2017
- 1 generation backK180353 Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd. · 2018
- This deviceK210663 Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK221312 Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK250431 Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK232709 Diode laser therapy deviceHebei Zhemai Technology Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK252048 808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251801 Diode laser device (BM091)Hebei Newangie Technology 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 backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 10 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 9 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 8 generations backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- 7 generations backK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- 6 generations backK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
- 5 generations backK112031 Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for…Alma Lasers, Inc. · 2011
- 4 generations backK123483 Diode LaserBeijing Syntech Laser CO., LTD. · 2013
- 3 generations backK141973 Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd. · 2014
- 2 generations backK162659 Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 2017
- 1 generation backK180353 Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd. · 2018
- This deviceK210663 Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd. · 2022 · cites it directly4descendants
- K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd. · 2025 · 2 generations on1descendant
- K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd. · 2023 · cites it directly1descendant
- K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K251801Diode laser device (BM091)Hebei Newangie Technology Co., Ltd. · 2025 · 2 generations on0descendants
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 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −10 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −9 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −8 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| −7 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| −6 | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms | Alma Lasers, Inc. | 2010 | — |
| −5 | K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with… | Alma Lasers, Inc. | 2011 | — |
| −4 | K123483 | Diode Laser | Beijing Syntech Laser CO., LTD. | 2013 | — |
| −3 | K141973 | Diode Laser Hair Removal System | Beijing Anchorfree Technology Co., Ltd. | 2014 | — |
| −2 | K162659 | Diode Laser Hair Removal System | Shandong Huamei Technology Co., Ltd. | 2017 | — |
| −1 | K180353 | Diode laser hair removal device | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K210663 | Dermatological Diode Laser Systems | Beijing HuaCheng Taike Technology Co., Ltd. | 2021 | — |
| +1 | K221312 | Diode Laser Hair Removal Device | Guangzhou Chuang Zao Mei Technology Co., Ltd. | 2022 | — |
| +2 | K250431 | Medical Diode Laser Hair Removal System (MNLT-D1) | Shandong Moonlight Electronics Tech Co., Ltd. | 2025 | — |
| +1 | K232709 | Diode laser therapy device | Hebei Zhemai Technology Co., Ltd. | 2023 | — |
| +3 | K252048 | 808nm semiconductor laser hair removal machine | Xi'An Taibo Electronic Technology Co., Ltd. | 2026 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K180353 | Diode laser hair removal deviceSummary page 6…K210663 6. Identification of Predicate Device Predicate Device 510(k) Number: K180353 Product Name: Diode Laser Hair Removal Device Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd… | 2018 |
| † | K142845 | SILKPRO laser hair removal system | 2015 |
What descends from it? (8)
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 29 years and passes through 13 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 63 ancestors have a recall of any class.
- Of its descendants, K221312 (Guangzhou Chuang Zao Mei Technology Co., Ltd., 2022) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K180353.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Dermatological Diode Laser Systems(Model:CM0 1D/CMO2D) 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/K210663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210663: Dermatological Diode Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210663
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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