510(k) · Cleared
ClearedAF Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ShenB Co., Ltd. · PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Cleared on Jul 20, 2022 as substantially equivalent to K153164 (Erchonia Medical, Inc., 2016) after a 70-day review. Its family tree reaches back 1 generation to 2016. 2 later devices descend from it.
- Decided
- Jul 20, 2022
- Review
- 70 days
- Class
- Class II
- Product code
- PDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K153164 (2016). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK153164 LunulaLaserErchonia Medical, Inc. · 2016
- This deviceK221363 AF LaserShenB Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK253960 Medicell Mycosis Laser (MCML24004)Medicell Healthcare Co.,LTD · 2026
- Descendant · cites it directly · 0 of its ownK241116 Onycho Laser VTerasysd&C, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K153164 | LunulaLaser | Erchonia Medical, Inc. | 2016 | — |
| 0 (this device) | K221363 | AF Laser | ShenB Co., Ltd. | 2022 | — |
| +1 | K253960 | Medicell Mycosis Laser (MCML24004) | Medicell Healthcare Co.,LTD | 2026 | — |
| +1 | K241116 | Onycho Laser V | Terasysd&C, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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 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 K253960 Medicell Mycosis Laser (MCML24004)score 11.3 · 2 generations · 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 |
|---|---|---|---|
| * | K153164 | LunulaLaserSummary page 4…surgery and in dermatology Regulation Number: 21 CFR 878.4810 (Product Code: PDZ) Legally Marketed Predicate Device: LunulaLaser (K153164) Regulatory Class: Class II Prescription Use Description of the AF Laser: The AF Laser is a… | 2016 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K253960 (Medicell Healthcare Co.,LTD, 2026) has gone furthest, with 0 descendants of its own.
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. 2022, 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 AF Laser device is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221363: AF Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221363
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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