510(k) K253960

Medicell Mycosis Laser (MCML24004) by Medicell Healthcare Co.,LTD — Product Code PDZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 9, 2026
Date Received: December 10, 2025
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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