510(k) · Cleared
ClearedIPL Hair Remover, Model: G993, G996, G998 and G885
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mywin Technology Co., Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Oct 4, 2021 as substantially equivalent to K160968 (Cyden Limited, 2016) and 2 other predicates after a 153-day review. Its family tree reaches back 19 generations to 1995. 1 later device descends from it.
- Decided
- Oct 4, 2021
- Review
- 153 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K950019 (1995). 56 ancestors in all, the oldest K892514 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 15 generations between
- 3 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 2 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 1 generation backK190820 Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd. · 2019
- This deviceK211368 IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK221679 IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd. · 2022
Show all 19 generations
- Root · 19 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 18 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 17 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 16 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 15 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 14 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 13 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 12 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 11 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 10 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 9 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 8 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 7 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 6 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 5 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 4 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 3 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 2 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 1 generation backK190820 Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd. · 2019
- This deviceK211368 IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K221679IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −18 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −17 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −16 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −15 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −14 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −13 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −12 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −11 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −10 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −9 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −8 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −7 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −6 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −5 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −4 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −3 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| −2 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| −1 | K190820 | Aimanfun Lumea Comfort | Kam Yuen Plastic Products, Ltd. | 2019 | — |
| 0 (this device) | K211368 | IPL Hair Remover, Model: G993, G996, G998 and G885 | Shenzhen Mywin Technology Co., Ltd. | 2021 | — |
| +1 | K221679 | IPL Hair Remover, Model: G993, G996, G998 and G885 | Shenzhen Mywin Technology Co., Ltd. | 2022 | — |
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 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 18.2 · 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? (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 |
|---|---|---|---|
| * | K160968 | iPulse SmoothSkin Gold Hair Removal DeviceSummary page 5…Name Gold Hair Removal Remover Comfort Device 510(k) K160968 K172791 K190820 Number Regulation 878.4810… | 2016 |
| * | K172791 | Lumilisse IPL Hair RemoverSummary page 5…al Remover Comfort Device 510(k) K160968 K172791 K190820 Number Regulation 878.4810 878.4810… | 2018 |
| * | K190820 | Aimanfun Lumea ComfortSummary page 5…Remover Comfort Device 510(k) K160968 K172791 K190820 Number Regulation 878.4810 878.4810 878.4810 Number R… | 2019 |
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 |
|---|---|---|---|
| K221679 | IPL Hair Remover, Model: G993, G996, G998 and G885 | 2022 | 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 26 years and passes through 13 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 56 ancestors has a recall of any class.
- Of its descendants, K221679 (Shenzhen Mywin Technology Co., Ltd., 2022) has gone furthest, with 0 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. 2021, 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?
The IPL Hair Remover Device, Model: G993, G996, G998 and G885 is indicated for the removal of unwanted hair under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
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/K211368 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211368: IPL Hair Remover, Model: G993, G996, G998 and G885.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211368
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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