FDA product code PDZ: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
PDZ is the FDA product code for lasers for temporary increase of clear nail in patients with onychomycosis. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. FDA has cleared 19 510(k) submissions under PDZ, 4 in the last five years, from 18 different applicants. The average 510(k) review took 204 days (median 186); 90 days on average over the last three years. FDA has posted 1 recall for PDZ devices.
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.).
Classification
| Field | Value |
|---|---|
| Device name | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Device class | Class II |
| Regulation | 21 CFR 878.4810 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for PDZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 128 |
| 2022 | 2 | 320 |
| 2024 | 1 | 90 |
| 2026 | 1 | 89 |
Compare with all 510(k) review times · Search every PDZ clearance
Top PDZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fotona D.D. | 2 | 2012-12-12 |
| Medicell Healthcare Co.,LTD | 1 | 2026-03-09 |
| Terasysd&C, Inc. | 1 | 2024-07-22 |
| Toefx, Inc. | 1 | 2022-11-17 |
| ShenB Co., Ltd. | 1 | 2022-07-20 |
13 more applicants have PDZ clearances. See the full list in Caduvo.
Most recent PDZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253960 | Medicell Healthcare Co.,LTD | Medicell Mycosis Laser (MCML24004) | 2026-03-09 | 89 |
| K241116 | Terasysd&C, Inc. | Onycho Laser V | 2024-07-22 | 90 |
| K211265 | Toefx, Inc. | TFX-LT2000 Therapy Light | 2022-11-17 | 570 |
| K221363 | ShenB Co., Ltd. | AF Laser | 2022-07-20 | 70 |
| K190034 | Footdocprenur, LLC | REMY Medical Therapy Laser System | 2019-05-15 | 128 |
Recalls for PDZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-11-20.
Frequently asked questions
What is FDA product code PDZ?
PDZ is the FDA product code for lasers for temporary increase of clear nail in patients with onychomycosis. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel.
What device class is PDZ?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code PDZ?
Across 19 cleared submissions the average was 204 days from receipt to decision (median 186).
Which companies have the most PDZ clearances?
Fotona D.D. (2); Medicell Healthcare Co.,LTD (1); Terasysd&C, Inc. (1); Toefx, Inc. (1); ShenB Co., Ltd. (1).
Have PDZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-11-20.
Next steps
- Run an FDA pathway report with predicate devices for product code PDZ
- Run a recall and safety report across every PDZ manufacturer
- Watch product code PDZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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