PDZ — Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis Class II
FDA product code PDZ covers "Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis", a Class II medical device regulated under 21 CFR 878.4810. Submissions are reviewed by the General, Plastic Surgery panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PDZ
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253960 | medicell healthcare co | Medicell Mycosis Laser (MCML24004) | March 9, 2026 |
| K241116 | terasysd and c | Onycho Laser V | July 22, 2024 |
| K211265 | toefx | TFX-LT2000 Therapy Light | November 17, 2022 |
| K221363 | shenb co | AF Laser | July 20, 2022 |
| K190034 | footdocprenur | REMY Medical Therapy Laser System | May 15, 2019 |
| K153164 | erchonia medical | LunulaLaser | June 3, 2016 |
| K150138 | aspen laser systems | Aspen Laser Systems Therapy Laser System | May 8, 2015 |
| K123014 | litecure | LITECURE THERAPY SYSTEM MODEL LTS-1500 | March 29, 2013 |
| K121508 | fotona | LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N | December 12, 2012 |
| K113843 | lutronic corporation | FREEDOM ND: YAG LASER SYSTEM | September 27, 2012 |
| K120938 | sheaumann laser | THE PL-1064 LASER SYSTEM | September 24, 2012 |
| K113702 | fotona | FOTONA XP ND: YAG LASER SYSTEM | March 28, 2012 |
| K113810 | alma lasers | MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES | March 8, 2012 |
| K110375 | blueshine | BLUESHINE'S GOLD SERIES | February 23, 2012 |
| K111483 | sciton | JOULE CLEARSENSE LASER SYSTEM | December 7, 2011 |
| K103338 | new star lasers | COOLTOUCH | November 1, 2011 |
| K110370 | light age | Q-CLEAR | September 15, 2011 |
| K103626 | cutera | CUTERA GENESISPLUS LASER SYSTEM | April 5, 2011 |
| K093547 | pinpointe usa | PINPOINTE FOOTLASER | October 15, 2010 |