510(k) · Cleared
ClearedIPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Xiazhifeng Electronic Co., Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on May 20, 2026 as substantially equivalent to K243036 (Bestway Plastic and Metal Products, Ltd., 2025) after an 86-day review. Its family tree reaches back 23 generations to 1995.
- Decided
- May 20, 2026
- Review
- 86 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 23 generations to K950019 (1995). 65 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 23 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 19 generations between
- 3 generations backK221214 Hand-held IPL device (IPL Home Use Hair Removal Device)…Shenzhen Ionka Medical Technology Co., Ltd. · 2022
- 2 generations backK230739 Hand-held IPL device (IPL Home Use Hair Removal Device), Model…Shenzhen Ionka Medical Technology Co., Ltd. · 2023
- 1 generation backK243036 IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04…Bestway Plastic and Metal Products, Ltd. · 2025
- This deviceK260594 IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG…Shenzhen Xiazhifeng Electronic Co., Ltd. · 2026
Show all 23 generations
- Root · 23 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 22 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 21 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 20 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 19 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 18 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 17 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 16 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 15 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 14 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 13 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 12 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 11 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 10 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 9 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 8 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 7 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 6 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 5 generations backK190820 Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd. · 2019
- 4 generations backK212907 Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd. · 2021
- 3 generations backK221214 Hand-held IPL device (IPL Home Use Hair Removal Device)…Shenzhen Ionka Medical Technology Co., Ltd. · 2022
- 2 generations backK230739 Hand-held IPL device (IPL Home Use Hair Removal Device), Model…Shenzhen Ionka Medical Technology Co., Ltd. · 2023
- 1 generation backK243036 IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04…Bestway Plastic and Metal Products, Ltd. · 2025
- This deviceK260594 IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG…Shenzhen Xiazhifeng Electronic Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −22 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −21 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −20 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −19 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −18 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −17 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −16 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −15 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −14 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −13 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −12 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −11 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −10 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −9 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −8 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −7 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| −6 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| −5 | K190820 | Aimanfun Lumea Comfort | Kam Yuen Plastic Products, Ltd. | 2019 | — |
| −4 | K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 | Kam Yuen Plastic Products, Ltd. | 2021 | — |
| −3 | K221214 | Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G… | Shenzhen Ionka Medical Technology Co., Ltd. | 2022 | — |
| −2 | K230739 | Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608… | Shenzhen Ionka Medical Technology Co., Ltd. | 2023 | — |
| −1 | K243036 | IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06… | Bestway Plastic and Metal Products, Ltd. | 2025 | — |
| 0 (this device) | K260594 | IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG… | Shenzhen Xiazhifeng Electronic 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 | 4 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K243036 | IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B…Summary page 5…HRL-05, BHRL-06, BHRL-06B, BHRL-07, Bestway Plastic And Metal BHRL-08, BHRL-09, K243036 June 6, 2025 Products Ltd. BHRL-10, BHRL-11,… | 2025 |
| † | K230097 | IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 | 2023 |
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 1.1 years on median.
- 1 of the 65 ancestors has a recall of any class.
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?
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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/K260594 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260594: IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260594
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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