510(k) · Cleared
ClearedRadiancy Skinstation with Modified Light Unit Addembly
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 Sep 2, 2005 after a 72-day review. The FDA summary names its predicate without a number. 171 later devices descend from it.
- Decided
- Sep 2, 2005
- Review
- 72 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
171 later devices descend from it, 3 citing it directly.
- This deviceK051671 Radiancy Skinstation with Modified Light Unit AddemblyRadiancy (Israel), Ltd. · 2005
- 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 171 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 171 · 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) | K051671 | Radiancy Skinstation with Modified Light Unit Addembly | Radiancy (Israel), Ltd. | 2005 | — |
| +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 |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 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? (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 SkinStation Photoepilation Systems Named without a submission number | |
| * | — | AesThera Corporation, Model AlP Named without a submission number | |
| * | — | Medical Bio Care Sweden AB., ProLite Named without a submission number | |
| * | — | Palomar Medical Technologies, Inc., StarLux Named without a submission number |
What descends from it? (171)
See all 1713 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?
- 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 intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-VI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051671 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051671: Radiancy Skinstation with Modified Light Unit Addembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051671
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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