# K253960: Medicell Mycosis Laser (MCML24004)

- Pathway: 510(k) (Traditional)
- Applicant: Medicell Healthcare Co.,LTD
- Decided: Mar 9, 2026 after 89 days
- Product code: PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K153164 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221363: AF Laser, ShenB Co., Ltd. (2022) Summary page 5.

## Indications for use
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.)

Source page: https://510kreport.com/device/K253960
Methodology: https://510kreport.com/methodology