510(k) · Cleared
ClearedHakon, Hakon Smart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical San Indústria DE Equipamentos Médicos Ltda. · GEX Powered Laser Surgical Instrument
Cleared on Sep 28, 2023 as substantially equivalent to K210663 (Beijing HuaCheng Taike Technology Co., Ltd., 2021) after a 92-day review. Its family tree reaches back 16 generations to 1992.
- Decided
- Sep 28, 2023
- Review
- 92 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). No later device cites it as a predicate yet.
- 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 deviceK231901 Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda. · 2023
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 deviceK231901 Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda. · 2023
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) | K231901 | Hakon, Hakon Smart | Medical San Indústria DE Equipamentos Médicos Ltda. | 2023 | — |
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 |
|---|---|---|---|
| * | K210663 | Dermatological Diode Laser SystemsSummary page 5…Model Company Beijing HuaCheng Taike K210663 CM01D/CM02D Technology Co., Ltd.… | 2021 |
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 31 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.
- 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. 2023, 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 (Model: Hakon and Hakon Smart) are intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Permanent hair reduction is defined as the stable, longterm reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231901 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231901: Hakon, Hakon Smart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231901
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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