510(k) · Cleared
ClearedSkinstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiancy (Israel), Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jun 19, 2003 after a 90-day review. The FDA summary names its predicate without a number. 222 later devices descend from it.
- Decided
- Jun 19, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
222 later devices descend from it, 10 citing it directly.
- This deviceK030897 SkinstationRadiancy (Israel), Ltd. · 2003
- Descendant · cites it directly · 169 of its ownK053527 Spectra Hair Removal LaserSpectragenics, Inc. · 2008
- Descendant · 2 generations on · 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 · 3 generations on · 148 of its ownK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- Descendant · 3 generations on · 140 of its ownK103560 Shaser Ipl Hair Removal SystemShaser, Inc. · 2011
Showing 5 of 222 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 222 · See all- K053527Spectra Hair Removal LaserSpectragenics, Inc. · 2008 · cites it directly169descendants
- K082298Flash N' GOHome Skinovations, Ltd. · 2008 · 2 generations on168descendants
- K090820Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009 · 2 generations on167descendants
- K103184Silk'n Flash N GOHome Skinovations, Ltd. · 2010 · 3 generations on148descendants
- K103560Shaser Ipl Hair Removal SystemShaser, Inc. · 2011 · 3 generations on140descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030897 | Skinstation | Radiancy (Israel), Ltd. | 2003 | — |
| +1 | K053527 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2008 | — |
| +2 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| +2 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| +3 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| +3 | K103560 | Shaser Ipl Hair Removal System | Shaser, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 10 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 12 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 16 | 0 |
| 2022 | 28 | 0 |
| 2023 | 33 | 0 |
| 2024 | 23 | 0 |
| 2025 | 19 | 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? (4)
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 |
|---|---|---|---|
| * | — | Radiancy’s SpaTouch Hair Removal System Named without a submission number | |
| * | — | Lumenis IPL Quantum SR Named without a submission number | |
| * | — | Medical Bio Care Sweden’s Prolite Named without a submission number | |
| * | — | Palomar’s EsteLux Named without a submission number |
What descends from it? (222)
See all 22210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053527 | Spectra Hair Removal Laser | 2008 | 169 |
| K043255 | Ellipse Light SPT | 2005 | 25 |
| K040659 | Mccue PLC Energist Ultra Variable Pulsed Light System | 2004 | 11 |
| K033181 | SPR System | 2003 | 11 |
| K041554 | Aip Intense Pulsed Light System | 2005 | 9 |
| K091664 | GSD Intense Pulsed Light System, Models: GP666C4, GP666C | 2009 | 4 |
| K073317 | Starlight, Model PD9012 | 2008 | 0 |
| K063060 | Blueshine Light Shine Systems, SP, Twin and Compact SP | 2006 | 0 |
| K052336 | Spectraquattro Pulsed Light System | 2005 | 0 |
| K050950 | Models Crystal 512, Record 618, Optima 518 Photo Epilation Systems | 2005 | 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?
- Of its descendants, K053527 (Spectragenics, Inc., 2008) has gone furthest, with 169 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Skinstation is a pulsed light device intended for hair removal and for treatment of pigmented and vascular lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030897 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030897: Skinstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030897
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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