The following data is part of a premarket notification filed by Shenb Co Ltd with the FDA for Af Laser.
| Device ID | K221363 |
| 510k Number | K221363 |
| Device Name: | AF Laser |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | ShenB Co Ltd ShenB Bldg 148 Seongsui-ro Seoul, KR 04796 |
| Contact | Sunny Kang |
| Correspondent | Connie Hoy Hoy And Associates 1830 Bonnie Way Sacramento, CA 95825 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-11 |
| Decision Date | 2022-07-20 |