510(k) · Cleared
ClearedSensilight/ Sensilight Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
El Global Trade, Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Aug 8, 2014 as substantially equivalent to K131870 (Home Skinovations, Ltd., 2013) and 1 other predicate after a 175-day review. Its family tree reaches back 13 generations to 1995. 14 later devices descend from it.
- Decided
- Aug 8, 2014
- Review
- 175 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K950019 (1995). 42 ancestors in all, the oldest K892514 (1990). 14 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 9 generations between
- 3 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 2 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 1 generation backK131870 Glide DeviceHome Skinovations, Ltd. · 2013
- This deviceK140381 Sensilight/ Sensilight PlusEl Global Trade, Ltd. · 2014
- Descendant · cites it directly · 13 of its ownK170269 Hee HR MiniOriental Inspiration Limited · 2017
- 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
- Descendant · 4 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
Show all 13 generations
- Root · 13 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 12 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 11 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 10 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 9 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 8 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 7 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 6 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 5 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 4 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 3 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 2 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 1 generation backK131870 Glide DeviceHome Skinovations, Ltd. · 2013
- This deviceK140381 Sensilight/ Sensilight PlusEl Global Trade, Ltd. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K170269Hee HR MiniOriental Inspiration Limited · 2017 · cites it directly13descendants
- 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
- K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd. · 2025 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −12 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −11 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −10 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −9 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −8 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −7 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −6 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −5 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −4 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −3 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −2 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −1 | K131870 | Glide Device | Home Skinovations, Ltd. | 2013 | — |
| 0 (this device) | K140381 | Sensilight/ Sensilight Plus | El Global Trade, Ltd. | 2014 | — |
| +1 | K170269 | Hee HR Mini | Oriental Inspiration Limited | 2017 | — |
| +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 | — |
| +4 | K250942 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP… | Shenzhen Ulike Smart Electronics 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K131870 | Glide DeviceSummary page 4…Light device is substantially equivalent to the following Predicate Device: 3.1 Home Skinovations Ltd.'s Glide device, cleared under 510(k) number K131870 at August 14th, 2013. 3.2 Home Skinovations Ltd.'s Silk'n Flash N Go, cleared under 510(k) number K103184 at Novem… | 2013 |
| * | K103184 | Silk'n Flash N GOSummary page 4…de device, cleared under 510(k) number K131870 at August 14th, 2013. 3.2 Home Skinovations Ltd.'s Silk'n Flash N Go, cleared under 510(k) number K103184 at November 10th, 2010. DEVICE DESCRIPTION 5-1… | 2010 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170269 | Hee HR Mini | 2017 | 13 |
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 19 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 42 ancestors has a recall of any class.
- Of its descendants, K170269 (Oriental Inspiration Limited, 2017) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K131870.
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. 2014, 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 sensiLight™/sensiLight™ Plus device is an over-the-counter device intended for the removal of unwanted hair. The sensiLight™/sensiLight™ Plus 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/K140381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140381: Sensilight/ Sensilight Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140381
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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