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510(k) K221363

AF Laser by ShenB Co., Ltd. — Product Code PDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2022
Date Received
May 11, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

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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