510(k) · Cleared
ClearedSILK'N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Home Skinovations, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jan 23, 2008 as substantially equivalent to K060839 (Palomar Medical Technologies, Inc., 2006) and 1 other predicate after a 104-day review. Its family tree reaches back 8 generations to 1995. 169 later devices descend from it.
- Decided
- Jan 23, 2008
- Review
- 104 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K950019 (1995). 22 ancestors in all. 169 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 7 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 6 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 5 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 4 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 3 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 2 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 1 generation backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- This deviceK072906 SILK'NHome Skinovations, Ltd. · 2008
- Descendant · cites it directly · 168 of its ownK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- Descendant · 2 generations on · 167 of its ownK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- Descendant · 2 generations on · 148 of its ownK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- Descendant · 2 generations on · 140 of its ownK103560 Shaser Ipl Hair Removal SystemShaser, Inc. · 2011
- Descendant · 3 generations on · 135 of its ownK120080 Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012
Showing 5 of 169 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 169 · See all- K082298Flash N' GOHome Skinovations, Ltd. · 2008 · cites it directly168descendants
- K090820Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009 · 2 generations on167descendants
- K103184Silk'n Flash N GOHome Skinovations, Ltd. · 2010 · 2 generations on148descendants
- K103560Shaser Ipl Hair Removal SystemShaser, Inc. · 2011 · 2 generations on140descendants
- K120080Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012 · 3 generations on135descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −7 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −6 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −5 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −4 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −3 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −2 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −1 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| 0 (this device) | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| +1 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| +2 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| +2 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| +2 | K103560 | Shaser Ipl Hair Removal System | Shaser, Inc. | 2011 | — |
| +3 | K120080 | Shaser HRS2 Hair Removal System | Shaser, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 15 | 0 |
| 2022 | 24 | 0 |
| 2023 | 30 | 0 |
| 2024 | 22 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K060839 | Abc Hair Removal SystemSummary page 1…and plastic surgery and in dermatology (21CRF §878.4810) Product code: GEX Predicate devices • ABC hair removal system, (K060839) Palomar Medical Technologies Inc. * SpaTouchPhotoepilation system, (K020856) Radiancy Ltd. Intended use:… | 2006 |
| * | K020856 | Spatouch Photoepilation SystemSummary page 1…ct code: GEX Predicate devices • ABC hair removal system, (K060839) Palomar Medical Technologies Inc. * SpaTouchPhotoepilation system, (K020856) Radiancy Ltd. Intended use: The Silk'n is intended for removal of unwanted hair by using selective photothermal treatme… | 2002 |
What descends from it? (169)
See all 1691 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082298 | Flash N' GO | 2008 | 168 |
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 13 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K082298 (Home Skinovations, Ltd., 2008) has gone furthest, with 168 descendants of its own.
- 2 other devices also cite its predicate K060839.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072906 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072906: SILK'N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072906
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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