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 Fotona D.D., Light Age, Inc. and Blueshine Srl.

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
Cleared Jun 03, 2016
LunulaLaser
K153164
Erchonia Medical, Inc.
General & Plastic Surgery · 214d
Cleared May 08, 2015
Aspen Laser Systems Therapy Laser System
K150138
Aspen Laser Systems, LLC
General & Plastic Surgery · 106d
Cleared Mar 29, 2013
LITECURE THERAPY SYSTEM MODEL LTS-1500
K123014
Litecure, LLC
General & Plastic Surgery · 183d
Cleared Dec 12, 2012
LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
K121508
Fotona D.D.
General & Plastic Surgery · 205d
Cleared Sep 27, 2012
FREEDOM ND: YAG LASER SYSTEM
K113843
Lutronic Corporation
General & Plastic Surgery · 274d
Cleared Sep 24, 2012
THE PL-1064 LASER SYSTEM
K120938
Sheaumann Laser, Inc.
General & Plastic Surgery · 186d
Cleared Mar 28, 2012
FOTONA XP ND: YAG LASER SYSTEM
K113702
Fotona D.D.
General & Plastic Surgery · 103d
Cleared Mar 08, 2012
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
K113810
Alma Lasers, Inc.
General & Plastic Surgery · 76d
Cleared Feb 23, 2012
BLUESHINE'S GOLD SERIES
K110375
Blueshine Srl
General & Plastic Surgery · 379d
Cleared Dec 07, 2011
JOULE CLEARSENSE LASER SYSTEM
K111483
Sciton, Inc
General & Plastic Surgery · 190d
Cleared Nov 01, 2011
COOLTOUCH
K103338
New Star Lasers, Inc.
General & Plastic Surgery · 351d
Cleared Sep 15, 2011
Q-CLEAR
K110370
Light Age, Inc.
General & Plastic Surgery · 219d
Cleared Apr 05, 2011
CUTERA GENESISPLUS LASER SYSTEM
K103626
Cutera, Inc.
General & Plastic Surgery · 116d

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 →