PDZ · Class II · 21 CFR 878.4810

FDA Product Code PDZ: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

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.).

Leading manufacturers include Footdocprenur, LLC, Toefx, Inc. and ShenB Co., Ltd..

19
Total
19
Cleared
204d
Avg days
2010
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 89d recently vs 211d historically

FDA 510(k) Cleared Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis Devices (Product Code PDZ)

19 devices
1–19 of 19
Cleared Mar 09, 2026
Medicell Mycosis Laser (MCML24004)
K253960
Medicell Healthcare Co.,LTD
General & Plastic Surgery · 89d
Cleared Jul 22, 2024
Onycho Laser V
K241116
Terasysd&C, Inc.
General & Plastic Surgery · 90d
Cleared Nov 17, 2022
TFX-LT2000 Therapy Light
K211265
Toefx, Inc.
General & Plastic Surgery · 570d
Cleared Jul 20, 2022
AF Laser
K221363
ShenB Co., Ltd.
General & Plastic Surgery · 70d
Cleared May 15, 2019
REMY Medical Therapy Laser System
K190034
Footdocprenur, LLC
General & Plastic Surgery · 128d

About Product Code PDZ - Regulatory Context

510(k) Submission Activity

19 total 510(k) submissions under product code PDZ since 2010, with 19 receiving FDA clearance (average review time: 204 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - PDZ Product Code

Recent submissions under PDZ have taken an average of 89 days to reach a decision - down from 211 days historically, suggesting improved FDA processing for this classification.

PDZ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →