510(k) · Cleared
ClearedRadiancy Acne System with Cleartouch Light Unit Assembly
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 Dec 11, 2003 after a 146-day review. The FDA summary names its predicate without a number. 175 later devices descend from it.
- Decided
- Dec 11, 2003
- Review
- 146 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
175 later devices descend from it, 9 citing it directly.
- This deviceK032205 Radiancy Acne System with Cleartouch Light Unit AssemblyRadiancy (Israel), Ltd. · 2003
- Descendant · cites it directly · 142 of its ownK043377 ZENOTyrell, Inc. · 2005
- Descendant · 2 generations on · 137 of its ownK080591 Tanda Skincare System, Model: PtscsPharos Life Corporation · 2008
- Descendant · cites it directly · 132 of its ownK060653 ThermaclearDermacare, Inc. · 2006
- Descendant · 2 generations on · 125 of its ownK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- Descendant · 3 generations on · 81 of its ownK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
Showing 5 of 175 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 175 · See all- K043377ZENOTyrell, Inc. · 2005 · cites it directly142descendants
- K080591Tanda Skincare System, Model: PtscsPharos Life Corporation · 2008 · 2 generations on137descendants
- K060653ThermaclearDermacare, Inc. · 2006 · cites it directly132descendants
- K121435Silkn BlueHome Skinovations, Ltd. · 2013 · 2 generations on125descendants
- K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014 · 3 generations on81descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032205 | Radiancy Acne System with Cleartouch Light Unit Assembly | Radiancy (Israel), Ltd. | 2003 | — |
| +1 | K043377 | ZENO | Tyrell, Inc. | 2005 | — |
| +2 | K080591 | Tanda Skincare System, Model: Ptscs | Pharos Life Corporation | 2008 | — |
| +1 | K060653 | Thermaclear | Dermacare, Inc. | 2006 | — |
| +2 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| +3 | K131461 | Lightstim for Acne/ Lightstim for Acne Mini | Led Intellectual Properties, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 9 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 8 | 0 |
| 2022 | 11 | 0 |
| 2023 | 12 | 0 |
| 2024 | 15 | 0 |
| 2025 | 41 | 0 |
| 2026 | 20 | 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? (1)
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 |
|---|---|---|---|
| * | — | ClearLight Phototherapy System, Model CT 420 Named without a submission number |
What descends from it? (175)
See all 1759 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043377 | ZENO | 2005 | 142 |
| K060653 | Thermaclear | 2006 | 132 |
| K043319 | Clareon and Solarus Pulsed Light Devices and Accessories | 2004 | 15 |
| K050165 | Modification to Ifl Professional System, Model C100 | 2005 | 10 |
| K060411 | Radiancy Cleartouch Lite Acne Clearance System | 2006 | 9 |
| K041554 | Aip Intense Pulsed Light System | 2005 | 9 |
| K081219 | Apollo Mini Ipl System | 2008 | 3 |
| K060567 | Spectragenics Ats-1 | 2006 | 2 |
| K052336 | Spectraquattro Pulsed Light System | 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, K043377 (Tyrell, Inc., 2005) has gone furthest, with 142 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 Radiancy Acne System with ClearTouch Light Unit Assembly ("Radiancy Acne System") is intended to provide phototherapeutic light to the body. The Radiancy Acne System is generally indicated to treat dermatological conditions. The Radiancy Acne System is specifically indicated to treat mild and moderate inflammatory acne which includes pustular inflammatory acne in patients with Fitzpatrick skin types I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032205 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032205: Radiancy Acne System with Cleartouch Light Unit Assembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032205
Report an extraction error
Are you the manufacturer?
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