PDZClass II
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
21 CFR 878.4810 / General, Plastic Surgery
PDZ is the FDA product code for Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "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.)". As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- PDZ
- Device name
- Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
- FDA 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.).
- Regulation
- 21 CFR 878.4810
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 19
- Ingested recalls
- 1
Clearances, product code PDZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 4 |
| 2012 | 6 |
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code PDZ| Applicant | Clearances |
|---|---|
| Fotona D.D. | 2 |
| Alma Lasers Ltd. | 1 |
| Aspen Laser Systems, LLC | 1 |
| Blueshine SRL | 1 |
| Cutera Inc | 1 |
| Erchonia Medical, Inc. | 1 |
| Footdocprenur, LLC | 1 |
| Light Age, Inc. | 1 |
| LiteCure, LLC | 1 |
| Lutronic Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.