510(k) · Cleared
ClearedHand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Ionka Medical Technology Co., Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Sep 21, 2022 as substantially equivalent to K160968 (Cyden Limited, 2016) and 3 other predicates after a 147-day review. Its family tree reaches back 20 generations to 1995. 12 later devices descend from it.
- Decided
- Sep 21, 2022
- Review
- 147 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 20 generations to K950019 (1995). 62 ancestors in all, the oldest K892514 (1990). 12 later devices descend from it, 1 citing it directly.
- Root · 20 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 16 generations between
- 3 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 2 generations backK190820 Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd. · 2019
- 1 generation backK212907 Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd. · 2021
- This deviceK221214 Hand-held IPL device (IPL Home Use Hair Removal Device)…Shenzhen Ionka Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 11 of its ownK230739 Hand-held IPL device (IPL Home Use Hair Removal Device), Model…Shenzhen Ionka Medical Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 6 of its ownK241998 Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20…Shenzhen Ulike Smart Electronics Co., Ltd. · 2024
- Descendant · 2 generations on · 3 of its ownK250942 Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW…Shenzhen Ulike Smart Electronics Co., Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK251000 Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06…Shenzhen Chuangtong Yigou Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK243036 IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04…Bestway Plastic and Metal Products, Ltd. · 2025
Show all 20 generations
- Root · 20 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 19 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 18 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 17 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 16 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 15 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 14 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 13 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 12 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 11 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 10 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 9 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 8 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 7 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 6 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 5 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 4 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 3 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 2 generations backK190820 Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd. · 2019
- 1 generation backK212907 Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd. · 2021
- This deviceK221214 Hand-held IPL device (IPL Home Use Hair Removal Device)…Shenzhen Ionka Medical Technology Co., Ltd. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd. · 2023 · cites it directly11descendants
- K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S…Shenzhen Ulike Smart Electronics Co., Ltd. · 2024 · 2 generations on6descendants
- K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd. · 2025 · 2 generations on3descendants
- K251000Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)Shenzhen Chuangtong Yigou Technology Co., Ltd. · 2025 · 2 generations on1descendant
- K243036IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B…Bestway Plastic and Metal Products, Ltd. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −19 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −18 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −17 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −16 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −15 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −14 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −13 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −12 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −11 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −10 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −9 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −8 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −7 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −6 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −5 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −4 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| −3 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| −2 | K190820 | Aimanfun Lumea Comfort | Kam Yuen Plastic Products, Ltd. | 2019 | — |
| −1 | K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 | Kam Yuen Plastic Products, Ltd. | 2021 | — |
| 0 (this device) | K221214 | Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G… | Shenzhen Ionka Medical Technology Co., Ltd. | 2022 | — |
| +1 | K230739 | Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608… | Shenzhen Ionka Medical Technology Co., Ltd. | 2023 | — |
| +2 | K241998 | Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S… | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024 | — |
| +2 | K250942 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP… | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025 | — |
| +2 | K251000 | Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07… | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2025 | — |
| +2 | K243036 | IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06… | Bestway Plastic and Metal Products, Ltd. | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.1 · 27 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K160968 | iPulse SmoothSkin Gold Hair Removal DeviceSummary page 5…II 3. Predicate Device: 510(K) Trade or Proprietary or Model Name Manufacturer K160968 Ipulse Smoothskin Gold Hair Removal Device Cyden Limited K170269 Hee HR Mini… | 2016 |
| * | K170269 | Hee HR MiniSummary page 5…tary or Model Name Manufacturer K160968 Ipulse Smoothskin Gold Hair Removal Device Cyden Limited K170269 Hee HR Mini Oriental Inspiration… | 2017 |
| * | K213558 | IPL Hair Removal DeviceSummary page 5…Oriental Inspiration Limited K213558 IPL Hair Removal Device Ulike Co., Ltd K212907 Aimanfun Lum… | 2022 |
| * | K212907 | Aimanfun Lumea Comfort, A-2789/A-3588Summary page 5…Limited K213558 IPL Hair Removal Device Ulike Co., Ltd K212907 Aimanfun Lumea Comfort, A-3588 Kam Yuen Plastic Products Ltd 4. Description… | 2021 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230739 | Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100… | 2023 | 11 |
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 27 years and passes through 13 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 62 ancestors has a recall of any class.
- Of its descendants, K230739 (Shenzhen Ionka Medical Technology Co., Ltd., 2023) has gone furthest, with 11 descendants of its own.
- 26 other devices also cite its predicate K160968.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
IPL home use hair removal device is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The IPL home use hair removal device is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.
The device is used for adults with Fitzpatrick skin types I – V.
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/K221214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221214: Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221214
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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