510(k) · Cleared
ClearedSilk'n Flash N GO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Home Skinovations, Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Nov 10, 2010 as substantially equivalent to K082298 (Home Skinovations, Ltd., 2008) and 2 other predicates after a 12-day review. Its family tree reaches back 11 generations to 1995. 148 later devices descend from it.
- Decided
- Nov 10, 2010
- Review
- 12 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K950019 (1995). 40 ancestors in all, the oldest K892514 (1990). 148 later devices descend from it, 7 citing it directly.
- Root · 11 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 7 generations between
- 3 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 2 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 1 generation backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- This deviceK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- Descendant · cites it directly · 135 of its ownK120080 Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012
- Descendant · cites it directly · 127 of its ownK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- Descendant · 2 generations on · 126 of its ownK123845 MESyneron Beauty, Ltd. · 2013
- Descendant · 2 generations on · 125 of its ownK131649 MESyneron Beauty, Ltd. · 2013
- Descendant · 2 generations on · 123 of its ownK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
Show all 11 generations
- Root · 11 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 10 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 9 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 8 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 7 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 6 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 5 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 4 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 3 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 2 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 1 generation backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- This deviceK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
Showing 5 of 148 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 148 · See all- K120080Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012 · cites it directly135descendants
- K121598ME HAIR2GOSyneron Medical, Ltd. · 2012 · cites it directly127descendants
- K123845MESyneron Beauty, Ltd. · 2013 · 2 generations on126descendants
- K131649MESyneron Beauty, Ltd. · 2013 · 2 generations on125descendants
- K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015 · 2 generations on123descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −10 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −9 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −8 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −7 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −6 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −5 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −4 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −3 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −2 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −1 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| 0 (this device) | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| +1 | K120080 | Shaser HRS2 Hair Removal System | Shaser, Inc. | 2012 | — |
| +1 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| +2 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| +2 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| +2 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 8 | 0 |
| 2019 | 4 | 0 |
| 2021 | 14 | 0 |
| 2022 | 23 | 0 |
| 2023 | 28 | 0 |
| 2024 | 20 | 0 |
| 2025 | 18 | 0 |
| 2026 | 10 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082298 | Flash N' GOSummary page 1…e in general and plastic surgery and in dermatology (21 CRE §878.48 10) Product code: GEX Predicate devices * Flash N Go (K082298), by Home Skinovations Ltd. * TRJA Laser Hair Removal Systemn(K090820),by Tria Beauty, Inc. o EpiLight and PhotoDerm HR (K9… | 2008 |
| * | K090820 | Tria Hair Removal Laser SystemSummary page 1…atology (21 CRE §878.48 10) Product code: GEX Predicate devices * Flash N Go (K082298), by Home Skinovations Ltd. * TRJA Laser Hair Removal Systemn(K090820),by Tria Beauty, Inc. o EpiLight and PhotoDerm HR (K991935), by ESC Medical system Inc. Intended use: The Flash N Go device… | 2009 |
| * | K991935 | Epilight Hair Removal System, Photoderm HR SystemSummary page 1…Predicate devices * Flash N Go (K082298), by Home Skinovations Ltd. * TRJA Laser Hair Removal Systemn(K090820),by Tria Beauty, Inc. o EpiLight and PhotoDerm HR (K991935), by ESC Medical system Inc. Intended use: The Flash N Go device is an over the counter device intended for the removal of unwa… | 2000 |
What descends from it? (148)
See all 1487 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 15 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 40 ancestors has a recall of any class.
- Of its descendants, K120080 (Shaser, Inc., 2012) has gone furthest, with 135 descendants of its own.
- 5 other devices also cite its predicate K082298.
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. 2010, 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?
Flash N Go is an over the counter device intended for the removal of unwanted hair.
Flash N Go is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103184: Silk'n Flash N GO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103184
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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