PDZ — Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis Class II
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 |