510(k) · Cleared
ClearedHee HR Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oriental Inspiration Limited · OHT Light Based Over-The-Counter Hair Removal
Cleared on May 3, 2017 as substantially equivalent to K140381 (El Global Trade, Ltd., 2014) and 1 other predicate after a 96-day review. Its family tree reaches back 14 generations to 1995. 13 later devices descend from it.
- Decided
- May 3, 2017
- Review
- 96 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K950019 (1995). 44 ancestors in all, the oldest K892514 (1990). 13 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 10 generations between
- 3 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 2 generations backK131870 Glide DeviceHome Skinovations, Ltd. · 2013
- 1 generation backK140381 Sensilight/ Sensilight PlusEl Global Trade, Ltd. · 2014
- This deviceK170269 Hee HR MiniOriental Inspiration Limited · 2017
- Descendant · cites it directly · 12 of its ownK221214 Hand-held IPL device (IPL Home Use Hair Removal Device)…Shenzhen Ionka Medical Technology Co., Ltd. · 2022
- Descendant · 2 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 · 3 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
- Descendant · 3 generations on · 3 of its ownK250942 Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW…Shenzhen Ulike Smart Electronics Co., Ltd. · 2025
- Descendant · 3 generations on · 1 of its ownK251000 Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06…Shenzhen Chuangtong Yigou Technology Co., Ltd. · 2025
Show all 14 generations
- Root · 14 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 13 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 12 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 11 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 10 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 9 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 8 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 7 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 6 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 5 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 4 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 3 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 2 generations backK131870 Glide DeviceHome Skinovations, Ltd. · 2013
- 1 generation backK140381 Sensilight/ Sensilight PlusEl Global Trade, Ltd. · 2014
- This deviceK170269 Hee HR MiniOriental Inspiration Limited · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd. · 2022 · cites it directly12descendants
- K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd. · 2023 · 2 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 · 3 generations on6descendants
- K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd. · 2025 · 3 generations on3descendants
- K251000Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)Shenzhen Chuangtong Yigou Technology Co., Ltd. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −13 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −12 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −11 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −10 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −9 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −8 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −7 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −6 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −5 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −4 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −3 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −2 | K131870 | Glide Device | Home Skinovations, Ltd. | 2013 | — |
| −1 | K140381 | Sensilight/ Sensilight Plus | El Global Trade, Ltd. | 2014 | — |
| 0 (this device) | K170269 | Hee HR Mini | Oriental Inspiration Limited | 2017 | — |
| +1 | K221214 | Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G… | Shenzhen Ionka Medical Technology Co., Ltd. | 2022 | — |
| +2 | K230739 | Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608… | Shenzhen Ionka Medical Technology Co., Ltd. | 2023 | — |
| +3 | K241998 | Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S… | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024 | — |
| +3 | K250942 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP… | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025 | — |
| +3 | K251000 | Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07… | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2025 | — |
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 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K140381 | Sensilight/ Sensilight PlusSummary page 4…4810 Device Class 2 3. Predicate Device: 510(K) Trade or Proprietary or Model Name Manufacturer K140381 sensiLight (sensiLight and sensiLight Plus) EL Global Trade Ltd. K141242 Glide device… | 2014 |
| * | K141242 | Glide DeviceSummary page 4…Proprietary or Model Name Manufacturer K140381 sensiLight (sensiLight and sensiLight Plus) EL Global Trade Ltd. K141242 Glide device Home skinovations Ltd 4. Description of Proposed Device: Th… | 2014 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221214 | Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100… | 2022 | 12 |
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 22 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 44 ancestors has a recall of any class.
- Of its descendants, K221214 (Shenzhen Ionka Medical Technology Co., Ltd., 2022) has gone furthest, with 12 descendants of its own.
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. 2017, 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?
HEE HR Mini is an over-the-counter device intended for the removal of unwanted hair. The HEE HR Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170269: Hee HR Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170269
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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