PDZ
- 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.).
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253960 | 2026-03-09 | Medicell Healthcare Co.,LTD | Medicell Mycosis Laser (MCML24004) | |
| K241116 | 2024-07-22 | Terasysd&C, Inc. | Onycho Laser V |
Official FDA classification page: PDZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).