510(k) · Cleared
ClearedThermaclear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dermacare, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 24, 2006 as substantially equivalent to K043377 (Tyrell, Inc., 2005) and 1 other predicate after a 225-day review. Its family tree reaches back 2 generations to 1998. 132 later devices descend from it.
- Decided
- Oct 24, 2006
- Review
- 225 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K982082 (1998). 4 ancestors in all. 132 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK982082 Handisol Wound HealingNational Biological Corp. · 1998
- 1 generation backK043377 ZENOTyrell, Inc. · 2005
- This deviceK060653 ThermaclearDermacare, Inc. · 2006
- Descendant · cites it directly · 125 of its ownK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- Descendant · 2 generations on · 81 of its ownK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- Descendant · 2 generations on · 75 of its ownK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- Descendant · 3 generations on · 58 of its ownK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- Descendant · 3 generations on · 55 of its ownK142246 LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015
Showing 5 of 132 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 132 · See all- K121435Silkn BlueHome Skinovations, Ltd. · 2013 · cites it directly125descendants
- K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014 · 2 generations on81descendants
- K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017 · 2 generations on75descendants
- K1718212 Face / Face EvolutionHeat IN A Click · 2018 · 3 generations on58descendants
- K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015 · 3 generations on55descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982082 | Handisol Wound Healing | National Biological Corp. | 1998 | — |
| −1 | K043377 | ZENO | Tyrell, Inc. | 2005 | — |
| 0 (this device) | K060653 | Thermaclear | Dermacare, Inc. | 2006 | — |
| +1 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| +2 | K131461 | Lightstim for Acne/ Lightstim for Acne Mini | Led Intellectual Properties, LLC | 2014 | — |
| +2 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| +3 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| +3 | K142246 | LightStim for Acne/ LightStim for Acne Mini | Led Intellectual Properties, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 12 | 0 |
| 2024 | 14 | 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? (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 |
|---|---|---|---|
| * | K043377 | ZENOSummary page 1…GEX) Predicate Devices: Tyrell, Inc. Zeno K043377 Radiancy (Israel) Ltd. Radiancy Acne S… | 2005 |
| * | K032205 | Radiancy Acne System with Cleartouch Light Unit AssemblySummary page 1…Radiancy (Israel) Ltd. Radiancy Acne System With ClearTouchTm K032205 Description of the Device: ThermaClearTm is a portable hand-held device that uses a short thermal pulse to treat mild to modera… | 2003 |
What descends from it? (132)
See all 1325 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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K121435 (Home Skinovations, Ltd., 2013) has gone furthest, with 125 descendants of its own.
- 6 other devices also cite its predicate K043377.
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?
ThermaClear is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060653: Thermaclear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060653
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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