510(k) · Cleared
ClearedClearflash AC2100 Cosmetic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearflash Technologies, Inc. · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Feb 8, 2012 as substantially equivalent to K060653 (Dermacare, Inc., 2006) and 2 other predicates after a 215-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Feb 8, 2012
- Review
- 215 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K982082 (1998). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982082 | Handisol Wound Healing | National Biological Corp. | 1998 | — |
| −2 | K043377 | ZENO | Tyrell, Inc. | 2005 | — |
| −1 | K060653 | Thermaclear | Dermacare, Inc. | 2006 | — |
| 0 (this device) | K111937 | Clearflash AC2100 Cosmetic System | Clearflash Technologies, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 OLP? 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 OLP device
- #1 K214103 Shani Darden LED light therapy maskscore 25.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K060653 | ThermaclearSummary page 1…Class 11- Laser instrument, surgical, powered (21 CIFR 878.4810, Product Code OLP) Predicate Devices and ThermaClear Device (K060653) 510(k) Numbers Zeno Acne Device (K043377) Radiancy ClearTouch… | 2006 |
| * | K043377 | ZENOSummary page 1…Product Code OLP) Predicate Devices and ThermaClear Device (K060653) 510(k) Numbers Zeno Acne Device (K043377) Radiancy ClearTouch Lite (K060411) Description of IDevice The ClearFlash AC… | 2005 |
| * | K060411 | Radiancy Cleartouch Lite Acne Clearance SystemSummary page 1…ThermaClear Device (K060653) 510(k) Numbers Zeno Acne Device (K043377) Radiancy ClearTouch Lite (K060411) Description of IDevice The ClearFlash AC2100 is a compact, handheld device that delivers a… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 7 ancestors has a recall.
- 4 other devices also cite its predicate K060653.
How does its category compare?
All OLP devicesOLP Over-The-Counter Powered Light Based Laser For Acne: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OLP
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLP
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLP
1in 2025
MAUDE reports naming product code OLP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 245 | 0 | 0 |
| 2014 | 3 | 255 | 0 | 1 |
| 2015 | 3 | 159 | 0 | 0 |
| 2016 | 6 | 99 | 0 | 1 |
| 2017 | 4 | 151 | 4 | 1 |
| 2018 | 5 | 104 | 0 | 7 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 6 | 260 | 0 | 7 |
| 2022 | 5 | 245 | 0 | 1 |
| 2023 | 3 | 109 | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 3 | 88 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ClearFlash AC2100 Cosmetic System 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/K111937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111937: Clearflash AC2100 Cosmetic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111937
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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