510(k) · Cleared
ClearedAimanfun Lumea Comfort
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kam Yuen Plastic Products, Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Oct 2, 2019 as substantially equivalent to K160968 (Cyden Limited, 2016) and 3 other predicates after a 184-day review. Its family tree reaches back 18 generations to 1995. 22 later devices descend from it.
- Decided
- Oct 2, 2019
- Review
- 184 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K950019 (1995). 55 ancestors in all, the oldest K892514 (1990). 22 later devices descend from it, 6 citing it directly.
- Root · 18 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 14 generations between
- 3 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 2 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 1 generation backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- This deviceK190820 Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd. · 2019
- Descendant · cites it directly · 15 of its ownK213558 IPL Hair Removal DeviceUlike Co., Ltd. · 2022
- Descendant · cites it directly · 14 of its ownK212907 Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd. · 2021
- Descendant · 2 generations on · 12 of its ownK221214 Hand-held IPL device (IPL Home Use Hair Removal Device)…Shenzhen Ionka Medical Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 11 of its ownK230739 Hand-held IPL device (IPL Home Use Hair Removal Device), Model…Shenzhen Ionka Medical Technology Co., Ltd. · 2023
- Descendant · 4 generations on · 6 of its ownK241998 Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20…Shenzhen Ulike Smart Electronics Co., Ltd. · 2024
Show all 18 generations
- Root · 18 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 17 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 16 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 15 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 14 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 13 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 12 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 11 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 10 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 9 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 8 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 7 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 6 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 5 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 4 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 3 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 2 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 1 generation backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- This deviceK190820 Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd. · 2019
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K213558IPL Hair Removal DeviceUlike Co., Ltd. · 2022 · cites it directly15descendants
- K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd. · 2021 · cites it directly14descendants
- K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd. · 2022 · 2 generations on12descendants
- K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd. · 2023 · 3 generations on11descendants
- K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S…Shenzhen Ulike Smart Electronics Co., Ltd. · 2024 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −17 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −16 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −15 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −14 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −13 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −12 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −11 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −10 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −9 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −8 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −7 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −6 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −5 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −4 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −3 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −2 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| −1 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| 0 (this device) | K190820 | Aimanfun Lumea Comfort | Kam Yuen Plastic Products, Ltd. | 2019 | — |
| +1 | K213558 | IPL Hair Removal Device | Ulike Co., Ltd. | 2022 | — |
| +1 | K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 | Kam Yuen Plastic Products, Ltd. | 2021 | — |
| +2 | K221214 | Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G… | Shenzhen Ionka Medical Technology Co., Ltd. | 2022 | — |
| +3 | K230739 | Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608… | Shenzhen Ionka Medical Technology Co., Ltd. | 2023 | — |
| +4 | K241998 | Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S… | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 OHT? 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 OHT device
- #1 K221002 IPL Hair Removal Device, Model (s): UI04A…score 36.1 · 20 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 |
|---|---|---|---|
| * | K160968 | iPulse SmoothSkin Gold Hair Removal DeviceSummary page 5…oth MINI RX System Remover 510(k) Number K160968 K161428 K172791 K 132170 Product Code OHT OHT OHT… | 2016 |
| * | K161428 | PerfectSmoothSummary page 5…MINI RX System Remover 510(k) Number K160968 K161428 K172791 K 132170 Product Code OHT OHT OHT ONF R… | 2017 |
| * | K172791 | Lumilisse IPL Hair RemoverSummary page 5…MINI RX System Remover 510(k) Number K160968 K161428 K172791 K 132170 Product Code OHT OHT OHT ONF Regulation Numb… | 2018 |
| * | K132170 | Shaser V-Mini RXSummary page 5…RX System Remover 510(k) Number K160968 K161428 K172791 K 132170 Product Code OHT OHT OHT ONF Regulation Number 878.… | 2013 |
What descends from it? (22)
See all 226 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213558 | IPL Hair Removal Device | 2022 | 15 |
| K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 | 2021 | 14 |
| K211368 | IPL Hair Remover, Model: G993, G996, G998 and G885 | 2021 | 1 |
| K230107 | Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 | 2023 | 0 |
| K212099 | Red Wave Hair Removal | 2021 | 0 |
| K211174 | IPL Hair Removal | 2021 | 0 |
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 24 years and passes through 12 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 55 ancestors has a recall of any class.
- Of its descendants, K213558 (Ulike Co., Ltd., 2022) has gone furthest, with 15 descendants of its own.
- 26 other devices also cite its predicate K160968.
How does its category compare?
All OHT devicesOHT Light Based Over-The-Counter Hair Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OHT
25in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHT
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHT
No recall names OHT since 2007.
Adverse event reports per year · OHT
6in 2025
MAUDE reports naming product code OHT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 166 | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 3 | 81 | 0 | 2 |
| 2017 | 6 | 87 | 0 | 0 |
| 2018 | 8 | 89 | 0 | 0 |
| 2019 | 7 | 64 | 0 | 2 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 12 | 89 | 0 | 1 |
| 2022 | 25 | 70 | 0 | 2 |
| 2023 | 32 | 83 | 0 | 6 |
| 2024 | 26 | 62 | 0 | 0 |
| 2025 | 25 | 87 | 0 | 6 |
| 2026 | 11 | 84 | 0 | — |
What is it indicated for?
The Aimanfun Lumea Comfort (Model: A-2788) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The Aimanfun Lumea Comfort is also intended for permanent reduction in unwanted hair. 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 regimen.
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/K190820 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190820: Aimanfun Lumea Comfort.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190820
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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