510(k) · Cleared
ClearedRadiancy Cleartouch Lite Acne Clearance System
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 Mar 22, 2006 as substantially equivalent to K032205 (Radiancy (Israel), Ltd., 2003) and 1 other predicate after a 34-day review. Its family tree reaches back 1 generation to 2003. 9 later devices descend from it.
- Decided
- Mar 22, 2006
- Review
- 34 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K032205 (2003). 2 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK032205 Radiancy Acne System with Cleartouch Light Unit AssemblyRadiancy (Israel), Ltd. · 2003
- This deviceK060411 Radiancy Cleartouch Lite Acne Clearance SystemRadiancy (Israel), Ltd. · 2006
- Descendant · cites it directly · 4 of its ownK062048 Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006
- Descendant · 2 generations on · 3 of its ownK083730 IsolazAesthera Corporation · 2009
- Descendant · cites it directly · 2 of its ownK080638 CLAROClrs Technology Corporation · 2008
- Descendant · 3 generations on · 1 of its ownK101415 TheraclearTheravant Corporation · 2010
- Descendant · 2 generations on · 1 of its ownK090744 CLAROClrs Technology Corporation · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006 · cites it directly4descendants
- K083730IsolazAesthera Corporation · 2009 · 2 generations on3descendants
- K080638CLAROClrs Technology Corporation · 2008 · cites it directly2descendants
- K101415TheraclearTheravant Corporation · 2010 · 3 generations on1descendant
- K090744CLAROClrs Technology Corporation · 2010 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032205 | Radiancy Acne System with Cleartouch Light Unit Assembly | Radiancy (Israel), Ltd. | 2003 | — |
| 0 (this device) | K060411 | Radiancy Cleartouch Lite Acne Clearance System | Radiancy (Israel), Ltd. | 2006 | — |
| +1 | K062048 | Aesthera Photopneumatic (PPX) System | Aesthera Corporation | 2006 | — |
| +2 | K083730 | Isolaz | Aesthera Corporation | 2009 | — |
| +1 | K080638 | CLARO | Clrs Technology Corporation | 2008 | — |
| +3 | K101415 | Theraclear | Theravant Corporation | 2010 | — |
| +2 | K090744 | CLARO | Clrs Technology Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 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 |
|---|---|---|---|
| * | K032205 | Radiancy Acne System with Cleartouch Light Unit AssemblySummary page 2…egistration Number: 9616256 Owner/operator number: 9040071 Predicate Devices Radiancy Acne System with ClearTouchTM Light Unit Assembry (K032205, K051268) Device Description The ClearTouch LiteTM is a pulsed-light, manually controlled system designed to deliver… | 2003 |
| * | K051268 | Radiance Acne System with Cleartouch Light UnitSummary page 2…on Number: 9616256 Owner/operator number: 9040071 Predicate Devices Radiancy Acne System with ClearTouchTM Light Unit Assembry (K032205, K051268) Device Description The ClearTouch LiteTM is a pulsed-light, manually controlled system designed to deliver light i… | 2005 |
What descends from it? (9)
3 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?
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 ClearTouch Lite Acne Clearance System (ClearTouch Lite) is intended to provide phototherapeutic light to the body. The ClearTouch Lite is generally indicated to treat dermatological conditions. The ClearTouch Lite is specifically indicated to treat mild and moderate inflammatory acne, which includes pustular inflammatory acne in patients with Fitzpatrick skin types I-VI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060411 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060411: Radiancy Cleartouch Lite Acne Clearance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060411
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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