510(k) · Cleared
ClearedDUO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stetic Medical Aesthetics Development (Shenzhen) Co.,Ltd · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Sep 1, 2016 as substantially equivalent to K140631 (Shaser, Inc., 2014) and 1 other predicate after an 87-day review. Its family tree reaches back 16 generations to 1995. 19 later devices descend from it.
- Decided
- Sep 1, 2016
- Review
- 87 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K950019 (1995). 49 ancestors in all, the oldest K892514 (1990). 19 later devices descend from it, 4 citing it directly.
- Root · 16 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 12 generations between
- 3 generations backK132266 Shaser HRS2 RX Hair Removal SystemShaser, Inc. · 2013
- 2 generations backK133201 Shaser V-Mini 2 Hair Removal SystemShaser, Inc. · 2014
- 1 generation backK140631 Lumena FH Hair Removal SystemShaser, Inc. · 2014
- This deviceK161565 DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd · 2016
- Descendant · cites it directly · 15 of its ownK213041 IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd. · 2021
- Descendant · 2 generations on · 11 of its ownK222537 IPL Hair Removal Device, Model (s)…Shenzhen Ishine Technology Company Limited · 2022
- Descendant · 3 generations on · 9 of its ownK240016 IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd. · 2024
- Descendant · 4 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 · 4 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
Show all 16 generations
- Root · 16 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 15 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 14 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 13 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 12 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 11 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 10 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 9 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 8 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 7 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 6 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 5 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 4 generations backK120080 Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012
- 3 generations backK132266 Shaser HRS2 RX Hair Removal SystemShaser, Inc. · 2013
- 2 generations backK133201 Shaser V-Mini 2 Hair Removal SystemShaser, Inc. · 2014
- 1 generation backK140631 Lumena FH Hair Removal SystemShaser, Inc. · 2014
- This deviceK161565 DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd · 2016
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd. · 2021 · cites it directly15descendants
- K222537IPL Hair Removal Device, Model (s): skn001,skn005,skn006,skn002,RoseSkinCo LumiShenzhen Ishine Technology Company Limited · 2022 · 2 generations on11descendants
- K240016IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd. · 2024 · 3 generations on9descendants
- K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S…Shenzhen Ulike Smart Electronics Co., Ltd. · 2024 · 4 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 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −15 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −14 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −13 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −12 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −11 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −10 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −9 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −8 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −7 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −6 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −5 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −4 | K120080 | Shaser HRS2 Hair Removal System | Shaser, Inc. | 2012 | — |
| −3 | K132266 | Shaser HRS2 RX Hair Removal System | Shaser, Inc. | 2013 | — |
| −2 | K133201 | Shaser V-Mini 2 Hair Removal System | Shaser, Inc. | 2014 | — |
| −1 | K140631 | Lumena FH Hair Removal System | Shaser, Inc. | 2014 | — |
| 0 (this device) | K161565 | DUO | Stetic Medical Aesthetics Development (Shenzhen) Co.,Ltd | 2016 | — |
| +1 | K213041 | IPL Hair Removal, Model: OBT-02 | Glan Electronics Co., Ltd. | 2021 | — |
| +2 | K222537 | IPL Hair Removal Device, Model (s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi | Shenzhen Ishine Technology Company Limited | 2022 | — |
| +3 | K240016 | IPL Hair Removal Device (YT01,YT02,YT03,YT04) | Shenzhen Jianrong Biomedical Electronics Co., Ltd. | 2024 | — |
| +4 | K241998 | Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S… | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024 | — |
| +4 | K250942 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP… | Shenzhen Ulike Smart Electronics Co., 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 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K140631 | Lumena FH Hair Removal SystemSummary page 4…Lumena FH Hair Device Name Sensi Light Mini Removal System 510(k) Number K140631 K140527 Product Code ONF OHT Regulation 878… | 2014 |
| * | K140527 | Sensilight MiniSummary page 4…Hair Device Name Sensi Light Mini Removal System 510(k) Number K140631 K140527 Product Code ONF OHT Regulation 878.4810 878… | 2014 |
What descends from it? (19)
See all 194 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 49 ancestors has a recall of any class.
- Of its descendants, K213041 (Glan Electronics Co., Ltd., 2021) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K140631.
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. 2016, 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 DUO (Model: IPL-HH380-IT) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. The DUO 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161565: DUO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161565
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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