K221363 is an FDA 510(k) clearance for the AF Laser. This device is classified as a Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (Class II - Special Controls, product code PDZ).
Submitted by ShenB Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on July 20, 2022, 70 days after receiving the submission on May 11, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. 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.)..
| 510(k) Number | K221363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2022 |
| Decision Date | July 20, 2022 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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.). |