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.).
| Device Type ID | 5861 |
| Device Name | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Physical State | Laser Device Outputting Energy At Different Wavelengths |
| Technical Method | Laser Energy Delivered To The Target Area By Scanning |
| Target Area | Toe Nail Of The Patients With Onychomycosis |
| Regulation Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4810 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PDZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5861 |
| Device | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Product Code | PDZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| CFR Regulation Number | 878.4810 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ASPEN LASER SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ERCHONIA MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ERCHONIA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operational Issue | 2 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hyperion Medical | II | Aug-18-2014 |