510(k) · Cleared
ClearedBraun Aura 9 (6042)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyden Limited · OHT Light Based Over-The-Counter Hair Removal
Cleared on Sep 25, 2026 as substantially equivalent to K143003 (Ipulse Limited, 2015) after a 105-day review. Its family tree reaches back 16 generations to 1995.
- Decided
- Sep 25, 2026
- Review
- 105 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K950019 (1995). 50 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 16 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 12 generations between
- 3 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 2 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 1 generation backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- This deviceK261977 Braun Aura 9 (6042)Cyden Limited · 2026
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 backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 3 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 2 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 1 generation backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- This deviceK261977 Braun Aura 9 (6042)Cyden Limited · 2026
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 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −3 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −2 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −1 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| 0 (this device) | K261977 | Braun Aura 9 (6042) | Cyden Limited | 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 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K243362 | FDA’s K243362 is SmoothSkin Pure Switch (SSC1) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2024 |
| Kept off the family tree | K230910 | FDA’s K230910 is NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2023 |
| * | K143003 | iPulse Smooth Skin Gold Hair Removal SystemSummary page 5…n_ _ S_k__ in i.e_ x_ p_ert _ ________________�[ �' O_H T_ ___� I K143003 I [ IIpulse SmoothSkin Gold H air Removal Device… | 2015 |
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 10 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 50 ancestors has a recall of any class.
- 5 other devices also cite its predicate K143003.
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 Braun Aura 9 is intended for the removal of unwanted hair. The Braun Aura 9 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/K261977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261977: Braun Aura 9 (6042).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261977
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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