510(k) · Cleared
ClearedCleane / Cleane Pop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicon Co., Ltd. · OZC Over The Counter Thermal Treatment For Acne.
Cleared on Feb 29, 2012 as substantially equivalent to K043377 (Tyrell, Inc., 2005) after a 293-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Feb 29, 2012
- Review
- 293 days
- Class
- Class II
- Product code
- OZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K982082 (1998). 4 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 |
|---|---|---|---|---|---|
| −2 | K982082 | Handisol Wound Healing | National Biological Corp. | 1998 | — |
| −1 | K043377 | ZENO | Tyrell, Inc. | 2005 | — |
| 0 (this device) | K111341 | Cleane / Cleane Pop | Medicon Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 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 OZC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K043377 | ZENOSummary page 1…Classification: Class 11 Classification regulation: 21 CFR89O.5740 Product Code: OZC 4. Predicate Device: Zeno by Tyrell, Inc. (K043377) 5. Description: The CLEANE and the CLEANE POP are potable had-held devices that produce accurately co… | 2005 |
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 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 4 ancestors has a recall.
- 6 other devices also cite its predicate K043377.
How does its category compare?
All OZC devicesOZC Over The Counter Thermal Treatment 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 · OZC
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OZC
Too few OZC 510(k)s in any year since 2007 to give a median.
Recalls per year · OZC
No recall names OZC since 2007.
Adverse event reports per year · OZC
No MAUDE report names OZC since 2007.
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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CLEANE and the CLEANE POP are 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/K111341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111341: Cleane / Cleane Pop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111341
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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