K253960
- 510(k) number
- K253960
- Device name
- Medicell Mycosis Laser (MCML24004)
- Applicant
- Medicell Healthcare Co.,LTD KR
- Product code
- PDZ — Lasers For Temporary Increase Of Clear Nail In Patie
- Decision date
- 2026-03-09
- Date received
- 2025-12-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253960.pdf
Official FDA record: K253960
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.