510(k) · Cleared
ClearedLED Therapy Device (Planar LED/Planar LED mini)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Leaflife Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Apr 12, 2022 as substantially equivalent to K202980 (Shenzhen Leaflife Technology Co., Ltd., 2020) and 2 other predicates after a 90-day review. Its family tree reaches back 19 generations to 1995. 1 later device descends from it.
- Decided
- Apr 12, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K950019 (1995). 101 ancestors in all, the oldest K871179 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 15 generations between
- 3 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 2 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 1 generation backK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- This deviceK220103 LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK230362 Planar LED mateShenzhen Leaflife Technology Co., Ltd. · 2023
Show all 19 generations
- Root · 19 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 18 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 17 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 16 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 15 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 14 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 13 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 12 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 11 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 10 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 9 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 8 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 7 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 6 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 5 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 4 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 3 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 2 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 1 generation backK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- This deviceK220103 LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −18 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −17 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −16 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −15 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −14 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −13 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −12 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −11 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −10 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −9 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −8 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −7 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −6 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −5 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −4 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −3 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| −2 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| −1 | K181568 | IPL Salon Hair Reduction System | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | 2018 | — |
| 0 (this device) | K220103 | LED Therapy Device (Planar LED/Planar LED mini) | Shenzhen Leaflife Technology Co., Ltd. | 2022 | — |
| +1 | K230362 | Planar LED mate | Shenzhen Leaflife Technology Co., Ltd. | 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 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K202980 | Laser Therapy DeviceSummary page 5…OHT Review Panel: General & Plastic Surgery III. PREDICATE DEVICE Predicate device (Primary) Laser Therapy Device, Model LM-L808A: K202980 Predicate device TRIA Laser Hair Removal System, Model TRIA: K120737 Predicate device IPL Salon Hai… | 2020 |
| * | K120737 | Tria Laser Hair Removal SystemSummary page 5…EDICATE DEVICE Predicate device (Primary) Laser Therapy Device, Model LM-L808A: K202980 Predicate device TRIA Laser Hair Removal System, Model TRIA: K120737 Predicate device IPL Salon Hair Reduction System, Model F60001: K181568 The pred… | 2012 |
| * | K181568 | IPL Salon Hair Reduction SystemSummary page 5…TRIA Laser Hair Removal System, Model TRIA: K120737 Predicate device IPL Salon Hair Reduction System, Model F60001: K181568 The predicates have not been subject to a design-related recall. IV. DEVICE DESCRIPTION The LED Therapy Device is a surgical… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230362 | Planar LED mate | 2023 | 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 27 years and passes through 13 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 101 ancestors have a recall of any class.
- Of its descendants, K230362 (Shenzhen Leaflife Technology Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 LED Therapy Device 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220103: LED Therapy Device (Planar LED/Planar LED mini).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220103
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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