510(k) · Cleared
ClearedBeurer IPL 8500 device/ IPL VelvetSkin Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Home Well Trading, Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Sep 19, 2018 as substantially equivalent to K161089 (El Global Trade, Ltd., 2016) and 1 other predicate after a 79-day review. Its family tree reaches back 15 generations to 1995. 1 later device descends from it.
- Decided
- Sep 19, 2018
- Review
- 79 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K950019 (1995). 46 ancestors in all, the oldest K892514 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 11 generations between
- 3 generations backK131870 Glide DeviceHome Skinovations, Ltd. · 2013
- 2 generations backK140527 Sensilight MiniEl Global Trade, Ltd. · 2014
- 1 generation backK161089 sensiLight MiniEl Global Trade, Ltd. · 2016
- This deviceK181734 Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK183260 Sensilight Pro / Pistol IPLEl Global Trade, Ltd. · 2019
Show all 15 generations
- Root · 15 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 14 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 13 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 12 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 11 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 10 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 9 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 8 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 7 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 6 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 5 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 4 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 3 generations backK131870 Glide DeviceHome Skinovations, Ltd. · 2013
- 2 generations backK140527 Sensilight MiniEl Global Trade, Ltd. · 2014
- 1 generation backK161089 sensiLight MiniEl Global Trade, Ltd. · 2016
- This deviceK181734 Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K183260Sensilight Pro / Pistol IPLEl Global Trade, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −14 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −13 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −12 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −11 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −10 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −9 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −8 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −7 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −6 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −5 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −4 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −3 | K131870 | Glide Device | Home Skinovations, Ltd. | 2013 | — |
| −2 | K140527 | Sensilight Mini | El Global Trade, Ltd. | 2014 | — |
| −1 | K161089 | sensiLight Mini | El Global Trade, Ltd. | 2016 | — |
| 0 (this device) | K181734 | Beurer IPL 8500 device/ IPL VelvetSkin Pro | Home Well Trading, Ltd. | 2018 | — |
| +1 | K183260 | Sensilight Pro / Pistol IPL | El Global Trade, Ltd. | 2019 | — |
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 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (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 |
|---|---|---|---|
| * | K161089 | sensiLight MiniSummary page 7…g Ltd. is substantially equivalent to the following Predicate Devices: 3.1 EL Global Trade Ltd.'s sensiLight Mini device, cleared under 510(k) numbers: K161089 on July 8, 2016. 3.2 Conair Corporation's Lumilisse hair remover, cleared under 510(k) number K172791 on January 18,… | 2016 |
| * | K172791 | Lumilisse IPL Hair RemoverSummary page 7…ght Mini device, cleared under 510(k) numbers: K161089 on July 8, 2016. 3.2 Conair Corporation's Lumilisse hair remover, cleared under 510(k) number K172791 on January 18, 2018. 4. DEVICE DESCRIPTION The Beurer IPL 8500 device is an intense pulse light hair reduction device.… | 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 |
|---|---|---|---|
| K183260 | Sensilight Pro / Pistol IPL | 2019 | 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 23 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 46 ancestors has a recall of any class.
- Of its descendants, K183260 (El Global Trade, Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K161089.
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. 2018, 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 IPL 8500 device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. IPL 8500 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181734: Beurer IPL 8500 device/ IPL VelvetSkin Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181734
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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