Medicell Mycosis Laser (MCML24004)— 510(k) K253960

Name: FDA 510(k) clearance K253960
Creator: U.S. Food and Drug Administration
Published: 2026-03-09

Substantially Equivalent

Medicell Healthcare Co.,LTD

FDA 510(k) clearance K253960 for Medicell Mycosis Laser (MCML24004), Substantially Equivalent on 2026-03-09. Applicant: Medicell Healthcare Co.,LTD. Device class: 2.

Clearance details

Applicant: Medicell Healthcare Co.,LTD
Product code: Code PDZ
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-12-10
Decision date: 2026-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.