# K221363: AF Laser

- Pathway: 510(k) (Traditional)
- Applicant: ShenB Co., Ltd.
- Decided: Jul 20, 2022 after 70 days
- Product code: PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K153164 (2016). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153164: LunulaLaser, Erchonia Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K253960: Medicell Mycosis Laser (MCML24004) (2026), 0 descendants of its own
- K241116: Onycho Laser V (2024), 0 descendants of its own

## Indications for use
The AF Laser device is indicated for use 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.).

Source page: https://510kreport.com/device/K221363
Methodology: https://510kreport.com/methodology