510(k) · Cleared
ClearedMedicell Mycosis Laser (MCML24004)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicell Healthcare Co.,LTD · PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Cleared on Mar 9, 2026 as substantially equivalent to K221363 (ShenB Co., Ltd., 2022) after an 89-day review. Its family tree reaches back 2 generations to 2016.
- Decided
- Mar 9, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- PDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K153164 (2016). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 PDZ? 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 PDZ device
- #1 K221363 AF Laserscore 9.7 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K221363 | AF LaserSummary page 5…Clear Nails 21 CFR §878.4810, Product Code PDZ Device Class: Class II Predicate Device: 510(k) No.: K221363 Model: AF Laser Manufacture: ShenB Co. Ltd… | 2022 |
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 10 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K221363.
How does its category compare?
All PDZ devicesPDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PDZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PDZ
196in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDZ
No recall names PDZ since 2007.
Adverse event reports per year · PDZ
1in 2019
MAUDE reports naming product code PDZ, 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 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 205 | 0 | 0 |
| 2012 | 6 | 196 | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Medicell Mycosis Laser is indicated for the temporary increase of clear nails in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum, and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253960 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253960: Medicell Mycosis Laser (MCML24004).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253960
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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