PDZ

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Product code
PDZ
Device name
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device class
Class 2
21 CFR
21 CFR 878.4810
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
19 (all years; only the last 3 years are listed here)

FDA classification definition

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.).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-03-09.

NumberDecision dateApplicantDevice nameSummary
K2539602026-03-09Medicell Healthcare Co.,LTDMedicell Mycosis Laser (MCML24004)PDF
K2411162024-07-22Terasysd&C, Inc.Onycho Laser VPDF

2 summaries are archived here for direct download.

Official FDA classification page: PDZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).