510(k) · Cleared
ClearedIpulse Hair Removal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyden Limited · OHT Light Based Over-The-Counter Hair Removal
Cleared on Jul 12, 2013 as substantially equivalent to K122280 (Cyden Limited, 2012) and 2 other predicates after a 154-day review. Its family tree reaches back 13 generations to 1995. 124 later devices descend from it.
- Decided
- Jul 12, 2013
- Review
- 154 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K950019 (1995). 30 ancestors in all. 124 later devices descend from it, 7 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 backK103560 Shaser Ipl Hair Removal SystemShaser, Inc. · 2011
- 1 generation backK122280 Ipulse Smoothskin Hair Removal SystemCyden Limited · 2012
- This deviceK130315 Ipulse Hair Removal SystemCyden Limited · 2013
- Descendant · cites it directly · 123 of its ownK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- Descendant · 2 generations on · 117 of its ownK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- Descendant · 3 generations on · 115 of its ownK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- Descendant · 4 generations on · 88 of its ownK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- Descendant · 3 generations on · 66 of its ownK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
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 backK103560 Shaser Ipl Hair Removal SystemShaser, Inc. · 2011
- 1 generation backK122280 Ipulse Smoothskin Hair Removal SystemCyden Limited · 2012
- This deviceK130315 Ipulse Hair Removal SystemCyden Limited · 2013
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 124 · See all- K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015 · cites it directly123descendants
- K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016 · 2 generations on117descendants
- K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017 · 3 generations on115descendants
- K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018 · 4 generations on88descendants
- K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130Shenzhen Bosidin Technology Co., Ltd. · 2019 · 3 generations on66descendants
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 | K103560 | Shaser Ipl Hair Removal System | Shaser, Inc. | 2011 | — |
| −1 | K122280 | Ipulse Smoothskin Hair Removal System | Cyden Limited | 2012 | — |
| 0 (this device) | K130315 | Ipulse Hair Removal System | Cyden Limited | 2013 | — |
| +1 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| +2 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| +3 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| +4 | K181568 | IPL Salon Hair Reduction System | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | 2018 | — |
| +3 | K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129… | Shenzhen Bosidin Technology Co., Ltd. | 2019 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2021 | 14 | 0 |
| 2022 | 23 | 0 |
| 2023 | 28 | 0 |
| 2024 | 20 | 0 |
| 2025 | 18 | 0 |
| 2026 | 10 | 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? (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 |
|---|---|---|---|
| * | K122280 | Ipulse Smoothskin Hair Removal SystemSummary page 1…surgery and dermatology Device Class: 21 CFR 878.4810 Predicate Devices: CyDen iPulse Smoothskin M100 series 2: K122280 Shaser IPL Hair Removal System Shaser Inc,… | 2012 |
| * | K103560 | Shaser Ipl Hair Removal SystemSummary page 1…s 2: K122280 Shaser IPL Hair Removal System Shaser Inc, Ki103560 Flash'N Go Home Skinovations Inc, K082298 D… | 2011 |
| * | K082298 | Flash N' GOSummary page 1…Ki103560 Flash'N Go Home Skinovations Inc, K082298 Device Description: The iPulse is an intense pulsed light (IPL) system composed of a base unit hous… | 2008 |
What descends from it? (124)
See all 1247 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143003 | iPulse Smooth Skin Gold Hair Removal System | 2015 | 123 |
| K241998 | Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S… | 2024 | 6 |
| K250942 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR… | 2025 | 3 |
| K260742 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR… | 2026 | 0 |
| K251398 | IPL Hair Removal Device (IPL-001, IPL-002) | 2025 | 0 |
| K250938 | Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01… | 2025 | 0 |
| K250384 | IPL400 | 2025 | 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 18 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 30 ancestors has a recall of any class.
- Of its descendants, K143003 (Ipulse Limited, 2015) has gone furthest, with 123 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. 2013, 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 Pulse Hair Removal System is an over-the-counter device intended for removal of unwanted hair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130315 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130315: Ipulse Hair Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130315
Report an extraction error
Are you the manufacturer?
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