510(k) · Cleared
ClearedSapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ONE BEAUTY Technology Co., Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Sep 18, 2026 as substantially equivalent to K242595 (Shenzhen Greatro Electronic Technology Co., Ltd., 2024) after a 58-day review. Its family tree reaches back 22 generations to 1995.
- Decided
- Sep 18, 2026
- Review
- 58 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 22 generations to K950019 (1995). 60 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 22 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 18 generations between
- 3 generations backK230097 IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103…Shenzhen Bsx Technology Electronics Co., Ltd. · 2023
- 2 generations backK232932 Intense Pulse Light Therapeutic ApparatusShenzhen Greatro Electronic Technology Co., Ltd. · 2023
- 1 generation backK242595 Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)Shenzhen Greatro Electronic Technology Co., Ltd. · 2024
- This deviceK262524 Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2…ONE BEAUTY Technology Co., Ltd. · 2026
Show all 22 generations
- Root · 22 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 21 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 20 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 19 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 18 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 17 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 16 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 15 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 14 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 13 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 12 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 11 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 10 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 9 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 8 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 7 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 6 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 5 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 4 generations backK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- 3 generations backK230097 IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103…Shenzhen Bsx Technology Electronics Co., Ltd. · 2023
- 2 generations backK232932 Intense Pulse Light Therapeutic ApparatusShenzhen Greatro Electronic Technology Co., Ltd. · 2023
- 1 generation backK242595 Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)Shenzhen Greatro Electronic Technology Co., Ltd. · 2024
- This deviceK262524 Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2…ONE BEAUTY Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −21 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −20 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −19 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −18 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −17 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −16 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −15 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −14 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −13 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −12 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −11 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −10 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −9 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −8 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −7 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −6 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| −5 | 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 | K230097 | IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105… | Shenzhen Bsx Technology Electronics Co., Ltd. | 2023 | — |
| −2 | K232932 | Intense Pulse Light Therapeutic Apparatus | Shenzhen Greatro Electronic Technology Co., Ltd. | 2023 | — |
| −1 | K242595 | Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) | Shenzhen Greatro Electronic Technology Co., Ltd. | 2024 | — |
| 0 (this device) | K262524 | Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B… | ONE BEAUTY Technology Co., Ltd. | 2026 | — |
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 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 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 |
|---|---|---|---|
| * | K242595 | Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)Summary page 5…Cleared Date Number Shenzhen Greatro Intense Pulse Light Therapeutic K242595 November 11, Electronic Technology Apparatus (Model(s): IPL-18 2024 Co., Lt… | 2024 |
| † | K251176 | IPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 15 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 60 ancestors has a recall of any class.
- 2 other devices also cite its predicate K242595.
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. 2026, 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 Sapphire Cooling IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262524: Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262524
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026