510(k) · Cleared
ClearedSILKPRO laser hair removal system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuhan Lotuxs Technology Co., Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Jul 1, 2015 as substantially equivalent to K090820 (Spectragenics, Inc., 2009) after a 274-day review. Its family tree reaches back 11 generations to 1995. 11 later devices descend from it.
- Decided
- Jul 1, 2015
- Review
- 274 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K950019 (1995). 28 ancestors in all. 11 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 7 generations between
- 3 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 2 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 1 generation backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- This deviceK142845 SILKPRO laser hair removal systemWuhan Lotuxs Technology Co., Ltd. · 2015
- Descendant · cites it directly · 6 of its ownK181019 Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK200525 Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK192569 Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK192516 Diode Laser 808nmBeijing Superlaser Technology Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK241860 Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited · 2024
Show all 11 generations
- Root · 11 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 10 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 9 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 8 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 7 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 6 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 5 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 4 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 3 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 2 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 1 generation backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- This deviceK142845 SILKPRO laser hair removal systemWuhan Lotuxs Technology Co., Ltd. · 2015
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd. · 2018 · cites it directly6descendants
- K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd. · 2020 · 2 generations on1descendant
- K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd. · 2019 · 2 generations on1descendant
- K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd. · 2019 · 2 generations on1descendant
- K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −10 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −9 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −8 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −7 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −6 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −5 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −4 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −3 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −2 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −1 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| 0 (this device) | K142845 | SILKPRO laser hair removal system | Wuhan Lotuxs Technology Co., Ltd. | 2015 | — |
| +1 | K181019 | Diode Laser System | Guangzhou Huafei Tongda Technology Co., Ltd. | 2018 | — |
| +2 | K200525 | Medical Diode Laser Hair Removal System | Weifang Mingliang Electronics Co., Ltd. | 2020 | — |
| +2 | K192569 | Diode Laser Therapy System | San HE Lefis Electronics Co., Ltd. | 2019 | — |
| +2 | K192516 | Diode Laser 808nm | Beijing Superlaser Technology Co., Ltd. | 2019 | — |
| +3 | K241860 | Diode Laser Hair Removal System | Beijing Winkonlaser Technology Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 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 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K090820 | Tria Hair Removal Laser SystemSummary page 6…7-1 SILKPRO Laser Hair Removal System 510(k) Submission through 510(k) No.K090820 (Decision Date – Dec 23, 2009), 5. Description of the Device [21 CFR 807.92(a) (4)] The SILKPRO Laser Hair Removal System e… | 2009 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K181019 (Guangzhou Huafei Tongda Technology Co., Ltd., 2018) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K090820.
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. 2015, 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?
SILKPRO is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. SILKPRO is also intended for permanent hair reduction 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/K142845 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142845: SILKPRO laser hair removal system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142845
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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