AF Laser
FDA 510(k) K221363 · ShenB Co., Ltd.
510(k) numberK221363
Submission
- Device name
- AF Laser
- Applicant
- ShenB Co., Ltd.
Seoul, KR - Received
- May 11, 2022
- Decision date
- July 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDZ – Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
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.).
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Questions and answers
When was AF Laser cleared by the FDA?
AF Laser (K221363) received a 510(k) decision of Substantially Equivalent on July 20, 2022, 70 days after the submission was received.
What is the product code of K221363?
The FDA product code is PDZ – Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis, a Class II (moderate risk) device regulated under 21 CFR 878.4810.