K153164 is an FDA 510(k) clearance for the LunulaLaser, a Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (Class II — Special Controls, product code PDZ), submitted by Erchonia Medical, Inc. (Mckinney, US). The FDA issued a Cleared decision on June 3, 2016, 214 days after receiving the submission on November 2, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K153164 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 02, 2015 |
| Decision Date | June 03, 2016 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | PDZ — Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| 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.). |